S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Comparing results of diagnostic procedures, such as PET scan and CT scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating patients with limited-stage diffuse large B-cell lymphoma.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
- To assess the 5-year progression-free survival (PFS) rate in patients with newly diagnosed limited-stage diffuse, large B-cell lymphoma (DLBCL) using positron emission tomography (PET)/CT scan to direct therapy after 3 courses of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP).
Secondary
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To evaluate PFS within the PET-positive (+) and PET-negative (-) subgroups of patients with newly diagnosed limited-stage DLBCL.
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To evaluate toxicity of the protocol treatments in this patient population.
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To evaluate the response probability in this patient population.
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To evaluate overall survival in the overall population, and within the PET+ and PET- subgroups.
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To estimate the rate of upstaging at baseline by PET/CT at baseline among patients newly diagnosed with limited-stage DLBCL by CT imaging and to describe outcomes in patients upstaged by PET/CT at baseline to advanced DLBCL.
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To describe outcomes in the subgroup of patients upstaged by PET/CT.
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To evaluate the association of germinal center B-cell subtype (GCB) vs stromal-1 vs stromal-2 gene expression signatures with PFS or overall survival.
OUTLINE: This is a multicenter study. Patients are stratified according to whether the patient was upstaged to advanced stage DLBCL, based on local review of the baseline PET/CT (yes vs no).
Chemotherapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV over 30-60 minutes, vincristine sulfate IV, and doxorubicin hydrochloride IV on day 1, and prednisone orally on days 1-5. Treatment repeats every 21 days for 3* courses. NOTE: *Patients found to have advanced stage DLBCL based on local review of the baseline PET scan receive 6 courses of R-CHOP.
FDG/PET - Radiotherapy: Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan at baseline, on days 15-18 of course 3, and at 12 weeks after completion of course 3. Patients with complete response (PET scan negative) receive one additional course of R-CHOP as above. Patients with partial response (PET scan positive) undergo involved-field radiotherapy (IFRT) 5 days a week for approximately 4-5 weeks.
Monoclonal antibody: Beginning 3-6 weeks after completion of IFRT, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes and rituximab IV on day 1 and on day 7, 8, or 9.
Patients may undergo blood sample collection at baseline for correlative studies. Bone marrow tissue samples may be also collected for correlative studies.
After completion of study therapy, patients are followed up every 6 months for 2 years and then yearly for 5 years.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: PET Negative: R-CHOP R-CHOP x 3 Cycles |
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Other: R-CHOP regimen
Other: laboratory biomarker analysis
|
Experimental: PET Positive: IFRT +Zevalin Standard IFRT+ Zevalin IV per ABW |
Biological: rituximab
Other: laboratory biomarker analysis
Radiation: fludeoxyglucose F 18
Radiation: selective external radiation therapy
Radiation: yttrium Y 90 ibritumomab tiuxetan
|
Outcome Measures
Primary Outcome Measures
- Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL) [up to 5 years]
Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. Progressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion >1.5 cm in the longest axis.
Secondary Outcome Measures
- Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) [up to 5 years]
Measured from date of interim positron emission tomography (PET)/computed tomography scan to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact.
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [up to 4 months or time of disease progression.]
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
- Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) [up to 5 years]
Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
- Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP [Up to 4 months]
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
- Association of Germinal Center B-cell Subtype (GCB) vs Stromal-1 vs Stromal-2 Gene Expression Signatures With PFS or Overall Survival [5 years]
Formalin-fixed, paraffin-embedded tissue from the diagnostic biopsy is collected and used to determine germinal center B-cell (GCB) phenotype. GCB subtype of DLBCL is defined by gene-expression profiling that is performed using quantitative nuclease protection assay (qNPA).
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL)
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Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group
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Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections
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Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible
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Patients must have non-bulky stage I or II disease by Ann Arbor classification
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This staging excludes FDG-PET evaluation
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Patients who have stage I or II non-bulky disease on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible
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Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration
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Low-resolution "localization" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol
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If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable
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Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma
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Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registration
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Patients may have either measurable or evaluable limited-stage DLBCL
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Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible
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If patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form (Form #15187)
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All measurable disease must be assessed within 28 days prior to registration
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Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration
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Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration
PATIENT CHARACTERISTICS:
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Zubrod performance status 0-2
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Absolute neutrophil count (ANC) ≥ 1,000/mm³
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Platelet count ≥ 100,000/mm³
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Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert syndrome)
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Patients must not be pregnant or nursing
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Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period
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Patients must not be known to be HIV-positive
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No other prior malignancy is allowed except for the following:
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Adequately treated basal cell or squamous cell skin cancer
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In situ cervical cancer
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Adequately treated stage I or II cancer from which the patient is currently in complete remission
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Any other cancer from which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
- Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Providence Cancer Center | Anchorage | Alaska | United States | 99508 |
2 | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | United States | 85724-5024 |
3 | Aurora Presbyterian Hospital | Aurora | Colorado | United States | 80012 |
4 | Boulder Community Hospital | Boulder | Colorado | United States | 80301-9019 |
5 | Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado | United States | 80933 |
6 | St. Anthony Central Hospital | Denver | Colorado | United States | 80204 |
7 | Kaiser Permanente - Denver | Denver | Colorado | United States | 80205 |
8 | Porter Adventist Hospital | Denver | Colorado | United States | 80210 |
9 | Presbyterian - St. Luke's Medical Center | Denver | Colorado | United States | 80218 |
10 | St. Joseph Hospital | Denver | Colorado | United States | 80218 |
11 | Rose Medical Center | Denver | Colorado | United States | 80220 |
12 | CCOP - Colorado Cancer Research Program | Denver | Colorado | United States | 80222 |
13 | Swedish Medical Center | Englewood | Colorado | United States | 80110 |
14 | St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado | United States | 81502 |
15 | North Colorado Medical Center | Greeley | Colorado | United States | 80631 |
16 | Kaiser Permanente - Lafayette | Lafayette | Colorado | United States | 80026 |
17 | Littleton Adventist Hospital | Littleton | Colorado | United States | 80122 |
18 | Sky Ridge Medical Center | Lone Tree | Colorado | United States | 80124 |
19 | Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado | United States | 80501 |
20 | McKee Medical Center | Loveland | Colorado | United States | 80539 |
21 | Parker Adventist Hospital | Parker | Colorado | United States | 80138 |
22 | St. Mary - Corwin Regional Medical Center | Pueblo | Colorado | United States | 81004 |
23 | North Suburban Medical Center | Thornton | Colorado | United States | 80229 |
24 | Exempla Lutheran Medical Center | Wheat Ridge | Colorado | United States | 80033 |
25 | Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut | United States | 06105 |
26 | Yale Cancer Center | New Haven | Connecticut | United States | 06520-8028 |
27 | Piedmont Hospital | Atlanta | Georgia | United States | 30309 |
28 | Northside Hospital Cancer Center | Atlanta | Georgia | United States | 30342-1611 |
29 | Saint Joseph's Hospital of Atlanta | Atlanta | Georgia | United States | 30342-1701 |
30 | CCOP - Atlanta Regional | Atlanta | Georgia | United States | 30342 |
31 | WellStar Cobb Hospital | Austell | Georgia | United States | 30106 |
32 | John B. Amos Cancer Center | Columbus | Georgia | United States | 31904 |
33 | Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur | Georgia | United States | 30033 |
34 | Piedmont Fayette Hospital | Fayetteville | Georgia | United States | 30214 |
35 | Gwinnett Medical Center | Lawrenceville | Georgia | United States | 30045 |
36 | Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta | Georgia | United States | 30060 |
37 | Southern Regional Medical Center | Riverdale | Georgia | United States | 30274-2600 |
38 | Harbin Clinic Cancer Center - Medical Oncology | Rome | Georgia | United States | 30165 |
39 | Kapiolani Medical Center at Pali Momi | 'Aiea | Hawaii | United States | 96701 |
40 | Oncare Hawaii, Incorporated - Pali Momi | 'Aiea | Hawaii | United States | 96701 |
41 | Leeward Radiation Oncology | 'Ewa Beach | Hawaii | United States | 96706 |
42 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813 |
43 | OnCare Hawaii, Incorporated - Lusitana | Honolulu | Hawaii | United States | 96813 |
44 | Queen's Cancer Institute at Queen's Medical Center | Honolulu | Hawaii | United States | 96813 |
45 | Straub Clinic and Hospital, Incorporated | Honolulu | Hawaii | United States | 96813 |
46 | OnCare Hawaii, Incorporated - Kuakini | Honolulu | Hawaii | United States | 96817-3169 |
47 | Hawaii Medical Center - East | Honolulu | Hawaii | United States | 96817 |
48 | Kuakini Medical Center | Honolulu | Hawaii | United States | 96817 |
49 | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | United States | 96826 |
50 | Castle Medical Center | Kailua | Hawaii | United States | 96734 |
51 | Kauai Medical Clinic | Lihue | Hawaii | United States | 96766 |
52 | Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho | United States | 83706 |
53 | Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise | Idaho | United States | 83712 |
54 | Illinois CancerCare - Bloomington | Bloomington | Illinois | United States | 61701 |
55 | St. Joseph Medical Center | Bloomington | Illinois | United States | 61701 |
56 | Graham Hospital | Canton | Illinois | United States | 61520 |
57 | Illinois CancerCare - Canton | Canton | Illinois | United States | 61520 |
58 | Illinois CancerCare - Carthage | Carthage | Illinois | United States | 62321 |
59 | Memorial Hospital | Carthage | Illinois | United States | 62321 |
60 | Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | United States | 60611-3013 |
61 | Hematology and Oncology Associates | Chicago | Illinois | United States | 60611 |
62 | Eureka Community Hospital | Eureka | Illinois | United States | 61530 |
63 | Illinois CancerCare - Eureka | Eureka | Illinois | United States | 61530 |
64 | Galesburg Clinic, PC | Galesburg | Illinois | United States | 61401 |
65 | Illinois CancerCare - Galesburg | Galesburg | Illinois | United States | 61401 |
66 | Illinois CancerCare - Havana | Havana | Illinois | United States | 62644 |
67 | Kellogg Cancer Care Center | Highland Park | Illinois | United States | 60035 |
68 | Provena St. Mary's Regional Cancer Center - Kankakee | Kankakee | Illinois | United States | 60901 |
69 | Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois | United States | 61443 |
70 | North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville | Illinois | United States | 60048 |
71 | Illinois CancerCare - Macomb | Macomb | Illinois | United States | 61455 |
72 | McDonough District Hospital | Macomb | Illinois | United States | 61455 |
73 | Illinois CancerCare - Monmouth | Monmouth | Illinois | United States | 61462 |
74 | OSF Holy Family Medical Center | Monmouth | Illinois | United States | 61462 |
75 | Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles | Illinois | United States | 60714 |
76 | BroMenn Regional Medical Center | Normal | Illinois | United States | 61761 |
77 | Community Cancer Center | Normal | Illinois | United States | 61761 |
78 | Illinois CancerCare - Community Cancer Center | Normal | Illinois | United States | 61761 |
79 | Community Hospital of Ottawa | Ottawa | Illinois | United States | 61350 |
80 | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | United States | 61350 |
81 | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | United States | 61554 |
82 | Illinois CancerCare - Pekin | Pekin | Illinois | United States | 61603 |
83 | Proctor Hospital | Peoria | Illinois | United States | 61614 |
84 | CCOP - Illinois Oncology Research Association | Peoria | Illinois | United States | 61615 |
85 | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | United States | 61615 |
86 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
87 | OSF St. Francis Medical Center | Peoria | Illinois | United States | 61637 |
88 | Illinois CancerCare - Peru | Peru | Illinois | United States | 61354 |
89 | Illinois Valley Community Hospital | Peru | Illinois | United States | 61354 |
90 | Illinois CancerCare - Princeton | Princeton | Illinois | United States | 61356 |
91 | Perry Memorial Hospital | Princeton | Illinois | United States | 61356 |
92 | Hematology Oncology Associates - Skokie | Skokie | Illinois | United States | 60076 |
93 | Illinois CancerCare - Spring Valley | Spring Valley | Illinois | United States | 61362 |
94 | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | United States | 46107 |
95 | Reid Hospital & Health Care Services | Richmond | Indiana | United States | 47374 |
96 | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | United States | 51101 |
97 | Mercy Medical Center - Sioux City | Sioux City | Iowa | United States | 51102 |
98 | St. Luke's Regional Medical Center | Sioux City | Iowa | United States | 51104 |
99 | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | United States | 66720 |
100 | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | United States | 67801 |
101 | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | United States | 67042 |
102 | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | United States | 66701 |
103 | Cancer Center of Kansas-Independence | Independence | Kansas | United States | 67301 |
104 | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | United States | 67068 |
105 | Lawrence Memorial Hospital | Lawrence | Kansas | United States | 66044 |
106 | Cancer Center of Kansas, PA - Liberal | Liberal | Kansas | United States | 67901 |
107 | Cancer Center of Kansas, PA - McPherson | McPherson | Kansas | United States | 67460 |
108 | Cancer Center of Kansas, PA - Newton | Newton | Kansas | United States | 67114 |
109 | Menorah Medical Center | Overland Park | Kansas | United States | 66209 |
110 | Saint Luke's Hospital - South | Overland Park | Kansas | United States | 66213 |
111 | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | United States | 67357 |
112 | CCOP - Kansas City | Prairie Village | Kansas | United States | 66208 |
113 | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | United States | 67124 |
114 | Cancer Center of Kansas, PA - Salina | Salina | Kansas | United States | 67401 |
115 | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | United States | 67152 |
116 | Associates in Womens Health, PA - North Review | Wichita | Kansas | United States | 67208 |
117 | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | United States | 67208 |
118 | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | United States | 67214 |
119 | CCOP - Wichita | Wichita | Kansas | United States | 67214 |
120 | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
121 | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | United States | 67156 |
122 | Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | United States | 40536-0093 |
123 | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | United States | 48106-0995 |
124 | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | United States | 48106 |
125 | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | United States | 48123-2500 |
126 | Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
127 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
128 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
129 | Genesys Regional Medical Center | Grand Blanc | Michigan | United States | 48439 |
130 | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | United States | 48236 |
131 | Foote Memorial Hospital | Jackson | Michigan | United States | 49201 |
132 | Borgess Medical Center | Kalamazoo | Michigan | United States | 49001 |
133 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007-3731 |
134 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007 |
135 | Sparrow Regional Cancer Center | Lansing | Michigan | United States | 48912-1811 |
136 | St. Mary Mercy Hospital | Livonia | Michigan | United States | 48154 |
137 | St. Joseph Mercy Oakland | Pontiac | Michigan | United States | 48341-2985 |
138 | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | United States | 48060 |
139 | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | United States | 48601 |
140 | St. John Macomb Hospital | Warren | Michigan | United States | 48093 |
141 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
142 | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
143 | Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | United States | 55805-1983 |
144 | CCOP - Duluth | Duluth | Minnesota | United States | 55805 |
145 | Miller - Dwan Medical Center | Duluth | Minnesota | United States | 55805 |
146 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
147 | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | United States | 55432 |
148 | Hutchinson Area Health Care | Hutchinson | Minnesota | United States | 55350 |
149 | HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | United States | 55109 |
150 | Minnesota Oncology - Maplewood | Maplewood | Minnesota | United States | 55109 |
151 | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
152 | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55415 |
153 | New Ulm Medical Center | New Ulm | Minnesota | United States | 56073 |
154 | Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | United States | 55422-2900 |
155 | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | United States | 55416 |
156 | Park Nicollet Cancer Center | Saint Louis Park | Minnesota | United States | 55416 |
157 | Regions Hospital Cancer Care Center | Saint Paul | Minnesota | United States | 55101 |
158 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
159 | St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | United States | 55379 |
160 | Lakeview Hospital | Stillwater | Minnesota | United States | 55082 |
161 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
162 | Willmar Cancer Center at Rice Memorial Hospital | Willmar | Minnesota | United States | 56201 |
163 | Minnesota Oncology - Woodbury | Woodbury | Minnesota | United States | 55125 |
164 | Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri | United States | 64111 |
165 | North Kansas City Hospital | Kansas City | Missouri | United States | 64116 |
166 | Heartland Hematology Oncology Associates, Incorporated | Kansas City | Missouri | United States | 64118 |
167 | Research Medical Center | Kansas City | Missouri | United States | 64132 |
168 | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri | United States | 64086 |
169 | Parvin Radiation Oncology | Liberty | Missouri | United States | 64068 |
170 | Heartland Regional Medical Center | Saint Joseph | Missouri | United States | 64506 |
171 | Saint Joseph Oncology, Incorporated | Saint Joseph | Missouri | United States | 64507 |
172 | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri | United States | 63110 |
173 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
174 | St. Vincent Healthcare Cancer Care Services | Billings | Montana | United States | 59101 |
175 | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | United States | 59102 |
176 | Billings Clinic - Downtown | Billings | Montana | United States | 59107-7000 |
177 | Bozeman Deaconess Cancer Center | Bozeman | Montana | United States | 59715 |
178 | St. James Healthcare Cancer Care | Butte | Montana | United States | 59701 |
179 | Great Falls Clinic - Main Facility | Great Falls | Montana | United States | 59405 |
180 | Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | United States | 59405 |
181 | St. Peter's Hospital | Helena | Montana | United States | 59601 |
182 | Glacier Oncology, PLLC | Kalispell | Montana | United States | 59901 |
183 | Kalispell Medical Oncology at KRMC | Kalispell | Montana | United States | 59901 |
184 | Kalispell Regional Medical Center | Kalispell | Montana | United States | 59901 |
185 | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | United States | 59807-7877 |
186 | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | United States | 59807 |
187 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
188 | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | United States | 27534 |
189 | Rex Cancer Center at Rex Hospital | Raleigh | North Carolina | United States | 27607 |
190 | Iredell Memorial Hospital | Statesville | North Carolina | United States | 28677 |
191 | MeritCare Broadway | Fargo | North Dakota | United States | 58102 |
192 | CCOP - MeritCare Hospital | Fargo | North Dakota | United States | 58122 |
193 | Roger Maris Cancer Center at MeritCare Hospital | Fargo | North Dakota | United States | 58122 |
194 | Grandview Hospital | Dayton | Ohio | United States | 45405 |
195 | Good Samaritan Hospital | Dayton | Ohio | United States | 45406 |
196 | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
197 | Samaritan North Cancer Care Center | Dayton | Ohio | United States | 45415 |
198 | CCOP - Dayton | Dayton | Ohio | United States | 45420 |
199 | Blanchard Valley Medical Associates | Findlay | Ohio | United States | 45840 |
200 | Middletown Regional Hospital | Franklin | Ohio | United States | 45005-1066 |
201 | Wayne Hospital | Greenville | Ohio | United States | 45331 |
202 | Charles F. Kettering Memorial Hospital | Kettering | Ohio | United States | 45429 |
203 | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | United States | 45373-1300 |
204 | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | United States | 45385 |
205 | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | United States | 74136 |
206 | Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | United States | 17822-0001 |
207 | Cancer Centers of the Carolinas - Faris Road | Greenville | South Carolina | United States | 29605 |
208 | Cancer Centers of the Carolinas - Grove Commons | Greenville | South Carolina | United States | 29605 |
209 | Greenville Hospital Cancer Center | Greenville | South Carolina | United States | 29605 |
210 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
211 | Cancer Centers of the Carolinas - Greer Medical Oncology | Greer | South Carolina | United States | 29650 |
212 | Cancer Centers of the Carolinas - Seneca | Seneca | South Carolina | United States | 29672 |
213 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
214 | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | United States | 29303 |
215 | Cancer Centers of the Carolinas - Spartanburg | Spartanburg | South Carolina | United States | 29307 |
216 | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | United States | 57117-5039 |
217 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229-3900 |
218 | Cancer Therapy and Research Center | San Antonio | Texas | United States | 78229 |
219 | University Hospital - San Antonio | San Antonio | Texas | United States | 78229 |
220 | Island Hospital Cancer Care Center at Island Hospital | Anacortes | Washington | United States | 98221 |
221 | St. Joseph Cancer Center | Bellingham | Washington | United States | 98225 |
222 | Olympic Hematology and Oncology | Bremerton | Washington | United States | 98310 |
223 | Highline Medical Center Cancer Center | Burien | Washington | United States | 98166 |
224 | Columbia Basin Hematology | Kennewick | Washington | United States | 99336 |
225 | Skagit Valley Hospital Cancer Care Center | Mount Vernon | Washington | United States | 98274 |
226 | Harrison Poulsbo Hematology and Onocology | Poulsbo | Washington | United States | 98370 |
227 | Harborview Medical Center | Seattle | Washington | United States | 98104 |
228 | Minor and James Medical, PLLC | Seattle | Washington | United States | 98104 |
229 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109 |
230 | Group Health Central Hospital | Seattle | Washington | United States | 98112 |
231 | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | United States | 98122-4307 |
232 | Polyclinic First Hill | Seattle | Washington | United States | 98122 |
233 | University Cancer Center at University of Washington Medical Center | Seattle | Washington | United States | 98195 |
234 | North Puget Oncology at United General Hospital | Sedro-Woolley | Washington | United States | 98284 |
235 | Cancer Care Northwest - Spokane South | Spokane | Washington | United States | 99202 |
236 | Evergreen Hematology and Oncology, PS | Spokane | Washington | United States | 99218 |
237 | Wenatchee Valley Medical Center | Wenatchee | Washington | United States | 98801-2028 |
238 | Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia | United States | 26506 |
239 | Gundersen Lutheran Center for Cancer and Blood | La Crosse | Wisconsin | United States | 54601 |
240 | Rocky Mountain Oncology | Casper | Wyoming | United States | 82609 |
Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Daniel O. Persky, MD, Yale University
Study Documents (Full-Text)
More Information
Publications
None provided.- CDR0000700624
- S1001
- U10CA032102
Study Results
Participant Flow
Recruitment Details | Patients with nonbulky (< 10 cm) stage I/II untreated DLBCL received 3 cycles of standard R-CHOP therapy and underwent a centrally reviewed interim PET/computed tomography scan (iPET). Those with a negative iPET proceeded with 1 additional cycle of R-CHOP, whereas those with a positive iPET received involved field radiation therapy followed by ibritumomab tiuxetan radioimmunotherapy. |
---|---|
Pre-assignment Detail |
Arm/Group Title | R-CHOP x 3 | R-CHOP x 6 | PET-negative: R-CHOP x 1 | PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin®) |
---|---|---|---|---|
Arm/Group Description | Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP For each cycle, R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 | Chemotherapy for up to 6 cycles, 21 days/per cycle, with R-CHOP For each cycle, R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 | Chemotherapy for 1 cycle, 21 days/per cycle, with R-CHOP R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 | Patients start Involved-Field Radiation Therapy (IFRT) as soon as possible after the Day 15-18 PET/CT scan that follows Cycle 3 of R-CHOP, but no later than Day 35 after initiation of Cycle 3 of R-CHOP. Zevalin® treatment begins 3-6 weeks after Radiation Therapy is completed. Radiation Therapy included: IFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy Radioimmunotherapy included: Rituximab: 250 mg/m^2 IV administration on Day 1 then 7, 8, or 9 Yttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9 |
Period Title: Initial Registration | ||||
STARTED | 158 | 1 | 0 | 0 |
Eligible and Evaluable | 132 | 1 | 0 | 0 |
COMPLETED | 129 | 1 | 0 | 0 |
NOT COMPLETED | 29 | 0 | 0 | 0 |
Period Title: Initial Registration | ||||
STARTED | 0 | 0 | 137 | 12 |
Eligible and Evaluable | 0 | 0 | 113 | 12 |
COMPLETED | 0 | 0 | 111 | 12 |
NOT COMPLETED | 0 | 0 | 26 | 0 |
Baseline Characteristics
Arm/Group Title | R-CHOP x 3 |
---|---|
Arm/Group Description | Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP For each cycle, R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 |
Overall Participants | 132 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
62
|
Age, Customized (Count of Participants) | |
Age > 60 years |
71
53.8%
|
Age <= 60 years |
61
46.2%
|
Sex: Female, Male (Count of Participants) | |
Female |
62
47%
|
Male |
70
53%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
6
4.5%
|
Not Hispanic or Latino |
121
91.7%
|
Unknown or Not Reported |
5
3.8%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
8
6.1%
|
Native Hawaiian or Other Pacific Islander |
1
0.8%
|
Black or African American |
5
3.8%
|
White |
115
87.1%
|
More than one race |
0
0%
|
Unknown or Not Reported |
3
2.3%
|
Zubrod Performance Status (Count of Participants) | |
0 |
89
67.4%
|
1 |
39
29.5%
|
2 |
4
3%
|
Stage (Count of Participants) | |
Stage I |
82
62.1%
|
Stage II |
50
37.9%
|
Symptoms (Count of Participants) | |
A |
109
82.6%
|
B |
23
17.4%
|
Elevated Lactate Dehydrogenase (LDH) (Count of Participants) | |
Yes |
19
14.4%
|
No |
113
85.6%
|
Extranodal Involvement (Count of Participants) | |
Yes |
57
43.2%
|
No |
75
56.8%
|
Stage-modified International Prognostic Index risk factors (Count of Participants) | |
0 |
35
26.5%
|
1 |
55
41.7%
|
2 |
37
28%
|
3 |
5
3.8%
|
Histologic Subtype (Count of Participants) | |
Diffuse large B-cell lymphoma, NOS |
95
72%
|
High-grade B-cell lymphoma with MYC and BCL2 or/and BCL6 rearrangements |
4
3%
|
High-grade B-cell lymphoma, NOS |
22
16.7%
|
T cell/histiocyte-rich large B-cell lymphoma |
2
1.5%
|
Central pathologic review not performed |
9
6.8%
|
Cell of Origin by Lymph2Cx (Count of Participants) | |
GCB |
59
44.7%
|
ABC |
20
15.2%
|
Unclassifiable |
8
6.1%
|
Double protein expressors (DPE) (Count of Participants) | |
DPE |
21
15.9%
|
Non-DPE |
97
73.5%
|
Indeterminate |
5
3.8%
|
Outcome Measures
Title | Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL) |
---|---|
Description | Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. Progressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion >1.5 cm in the longest axis. |
Time Frame | up to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable patients were included in the analysis. The patient who was upstaged at baseline by PET/CT was not included. |
Arm/Group Title | R-CHOP x 3 Followed by PET-directed Therapy |
---|---|
Arm/Group Description | R-CHOP x 3: Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP For each cycle, R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 PET-directed therapy included: PET-negative: R-CHOP x 1 PET-positive: IFRT + Yttrium-90 ibritumomab tiuxetan R-CHOP x 1: 1 cycle of R-CHOP, 21 days/cycle Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 IFRT + Yttrium-90 ibritumomab tiuxetan included: IFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy Rituximab: 250 mg/m^2 IV administration on Day 1 then 7, 8, or 9 Yttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9 |
Measure Participants | 132 |
Number (95% Confidence Interval) [percentage of participants] |
87
65.9%
|
Title | Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) |
---|---|
Description | Measured from date of interim positron emission tomography (PET)/computed tomography scan to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. |
Time Frame | up to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable patients who had interim PET/CT performed were included in the analysis. The patient who was upstaged at baseline by PET/CT was not included. |
Arm/Group Title | Interim PET-negative | Interim PET-positive |
---|---|---|
Arm/Group Description | Interim PET/CT scan was performed on Day 15-18 of Cycle 3 of R-CHOP chemotherapy. PET/CT scans were centrally reviewed and scored. Negative: no uptake uptake ≤ mediastinum uptake > mediastinum but ≤ liver | Interim PET/CT scan was performed on Day 15-18 of Cycle 3 of R-CHOP chemotherapy. PET/CT scans were centrally reviewed and scored. Positive: 4 uptake > liver in some sites even if uptake ≤ liver or mediastinum at other sites 5 uptake > liver in over 90% of sites or development of new uptake consistent with progressive disease |
Measure Participants | 114 | 14 |
Number (95% Confidence Interval) [percentage of participants] |
89
67.4%
|
86
NaN
|
Title | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
---|---|
Description | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. |
Time Frame | up to 4 months or time of disease progression. |
Outcome Measure Data
Analysis Population Description |
---|
Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included. |
Arm/Group Title | R-CHOP x 3 | R-CHOP x 6 | PET-negative: R-CHOP x 1 | PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin® |
---|---|---|---|---|
Arm/Group Description | Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP For each cycle, R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 | Chemotherapy for up to 6 cycles, 21 days/per cycle, with R-CHOP For each cycle, R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 | Chemotherapy for 1 cycle, 21 days/per cycle, with R-CHOP R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 | Patients start Involved-Field Radiation Therapy (IFRT) as soon as possible after the Day 15-18 PET/CT scan that follows Cycle 3 of R-CHOP, but no later than Day 35 after initiation of Cycle 3 of R-CHOP. Zevalin® treatment begins 3-6 weeks after Radiation Therapy is completed. Radiation Therapy included: IFRT:180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy Radioimmunotherapy included: Rituximab: 250 mg/m^2 IV administration on Day 1 then 7, 8, or 9 Yttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9 |
Measure Participants | 132 | 1 | 113 | 12 |
Alanine aminotransferase increased |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
Anemia |
7
5.3%
|
0
NaN
|
2
NaN
|
1
NaN
|
Anorexia |
1
0.8%
|
0
NaN
|
1
NaN
|
0
NaN
|
Bone pain |
1
0.8%
|
0
NaN
|
0
NaN
|
0
NaN
|
CD4 lymphocytes decreased |
1
0.8%
|
0
NaN
|
0
NaN
|
0
NaN
|
Catheter related infection |
1
0.8%
|
0
NaN
|
0
NaN
|
0
NaN
|
Cough |
1
0.8%
|
0
NaN
|
0
NaN
|
0
NaN
|
Diarrhea |
2
1.5%
|
0
NaN
|
0
NaN
|
0
NaN
|
Dyspnea |
3
2.3%
|
0
NaN
|
0
NaN
|
0
NaN
|
Edema limbs |
1
0.8%
|
0
NaN
|
0
NaN
|
0
NaN
|
Endocrine disorders - Other, specify |
1
0.8%
|
0
NaN
|
0
NaN
|
0
NaN
|
Fall |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
Fatigue |
3
2.3%
|
0
NaN
|
1
NaN
|
0
NaN
|
Febrile neutropenia |
13
9.8%
|
0
NaN
|
2
NaN
|
0
NaN
|
Generalized muscle weakness |
1
0.8%
|
0
NaN
|
0
NaN
|
0
NaN
|
Hyperglycemia |
3
2.3%
|
0
NaN
|
1
NaN
|
0
NaN
|
Hypertension |
1
0.8%
|
0
NaN
|
0
NaN
|
0
NaN
|
Hypocalcemia |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
Hypokalemia |
2
1.5%
|
0
NaN
|
1
NaN
|
0
NaN
|
Hyponatremia |
1
0.8%
|
0
NaN
|
1
NaN
|
0
NaN
|
Hypotension |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
Hypoxia |
0
0%
|
0
NaN
|
2
NaN
|
0
NaN
|
Leukemia secondary to oncology chemotherapy |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
Lung infection |
2
1.5%
|
0
NaN
|
0
NaN
|
0
NaN
|
Lymphocyte count decreased |
16
12.1%
|
0
NaN
|
9
NaN
|
2
NaN
|
Nausea |
1
0.8%
|
0
NaN
|
0
NaN
|
0
NaN
|
Nervous system disorders - Other, specify |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
Neutrophil count decreased |
34
25.8%
|
0
NaN
|
11
NaN
|
2
NaN
|
Peripheral sensory neuropathy |
1
0.8%
|
0
NaN
|
1
NaN
|
0
NaN
|
Platelet count decreased |
5
3.8%
|
0
NaN
|
4
NaN
|
3
NaN
|
Resp, thoracic and mediastinal disorders - Other |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
Sepsis |
2
1.5%
|
0
NaN
|
0
NaN
|
0
NaN
|
Skin infection |
1
0.8%
|
0
NaN
|
1
NaN
|
0
NaN
|
Stroke |
1
0.8%
|
0
NaN
|
0
NaN
|
0
NaN
|
Thromboembolic event |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
Urinary tract infection |
3
2.3%
|
0
NaN
|
0
NaN
|
0
NaN
|
Weight loss |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
White blood cell decreased |
26
19.7%
|
0
NaN
|
12
NaN
|
2
NaN
|
Title | Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) |
---|---|
Description | Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. |
Time Frame | up to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable patients were included in the analysis. The patient who was upstaged at baseline by PET/CT was not included. |
Arm/Group Title | R-CHOP x 3 Followed by PET-directed Therapy |
---|---|
Arm/Group Description | R-CHOP x 3: Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP For each cycle, R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 PET-directed therapy included: PET-negative: R-CHOP x 1 PET-positive: IFRT + Yttrium-90 ibritumomab tiuxetan R-CHOP x 1: 1 cycle of R-CHOP, 21 days/cycle Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 IFRT + Yttrium-90 ibritumomab tiuxetan included: IFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy Rituximab: 250 mg/m^2 IV administration on Day 1 then 7, 8, or 9 Yttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9 |
Measure Participants | 132 |
Number (95% Confidence Interval) [percentage of participants] |
89
67.4%
|
Title | Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP |
---|---|
Description | Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site. |
Time Frame | Up to 4 months |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable patients who treated with PET-directed therapy based on FDG-PET imaging after 3 cycles of R-CHOP were included in the analysis. |
Arm/Group Title | R-CHOP x 3 Followed by R-CHOP x 1 in Interim PET-negative Patients | R-CHOP x 3 Followed by IFRT + Yttrium-90 Ibritumomab Tiuxetan in Interim PET-positive Patients |
---|---|---|
Arm/Group Description | R-CHOP x 3: Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP For each cycle, R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 PET-directed therapy included: PET-negative: R-CHOP x 1 R-CHOP x 1: 1 cycle of R-CHOP, 21 days/cycle Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 | R-CHOP x 3: Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP For each cycle, R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 PET-directed therapy included: PET-positive: IFRT + Yttrium-90 ibritumomab tiuxetan IFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy Rituximab: 250 mg/m^2 IV administration on Day 1 then 7, 8, or 9 Yttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9 |
Measure Participants | 113 | 12 |
Complete Response |
112
84.8%
|
8
NaN
|
Partial Response |
0
0%
|
4
NaN
|
Inadequate Assessment |
1
0.8%
|
0
NaN
|
Title | Association of Germinal Center B-cell Subtype (GCB) vs Stromal-1 vs Stromal-2 Gene Expression Signatures With PFS or Overall Survival |
---|---|
Description | Formalin-fixed, paraffin-embedded tissue from the diagnostic biopsy is collected and used to determine germinal center B-cell (GCB) phenotype. GCB subtype of DLBCL is defined by gene-expression profiling that is performed using quantitative nuclease protection assay (qNPA). |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | up to 4 months or time of disease progression | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | The total number or participants at risk in this section is the number or participants in each arm that are eligible and evaluable. | |||||||
Arm/Group Title | R-CHOP x 3 | R-CHOP x 6 | PET-negative: R-CHOP x 1 | PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin®) | ||||
Arm/Group Description | Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP For each cycle, R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 | Chemotherapy for up to 6 cycles, 21 days/per cycle, with R-CHOP For each cycle, R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 | Chemotherapy for 1 cycle, 21 days/per cycle, with R-CHOP R-CHOP therapy included: Rituximab: 375 mg/m^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m^2 IV administration on Day 1 Doxorubicin: 50 mg/m^2 IV administration on Day 1 Vincristine: 1.4 mg/m^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 2 | Patients start Involved-Field Radiation Therapy (IFRT) as soon as possible after the Day 15-18 PET/CT scan that follows Cycle 3 of R-CHOP, but no later than Day 35 after initiation of Cycle 3 of R-CHOP. Zevalin® treatment begins 3-6 weeks after Radiation Therapy is completed. Radiation Therapy included: IFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy Radioimmunotherapy included: Rituximab: 250 mg/m^2 IV administration on Day 1 then 7, 8, or 9 Yttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9 | ||||
All Cause Mortality |
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R-CHOP x 3 | R-CHOP x 6 | PET-negative: R-CHOP x 1 | PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin®) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Serious Adverse Events |
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R-CHOP x 3 | R-CHOP x 6 | PET-negative: R-CHOP x 1 | PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin®) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/132 (1.5%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
General disorders | ||||||||
Sudden death NOS | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Infections and infestations | ||||||||
Sepsis | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Leukemia secondary to oncology chemotherapy | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Respiratory, thoracic and mediastinal disorders | ||||||||
Hypoxia | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Resp, thoracic and mediastinal disorders - Other | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Other (Not Including Serious) Adverse Events |
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R-CHOP x 3 | R-CHOP x 6 | PET-negative: R-CHOP x 1 | PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin®) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 130/132 (98.5%) | 1/1 (100%) | 105/113 (92.9%) | 11/12 (91.7%) | ||||
Blood and lymphatic system disorders | ||||||||
Anemia | 68/132 (51.5%) | 1/1 (100%) | 45/113 (39.8%) | 5/12 (41.7%) | ||||
Blood and lymphatic system disorders - Other | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Febrile neutropenia | 13/132 (9.8%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Lymph node pain | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Cardiac disorders | ||||||||
Atrial fibrillation | 2/132 (1.5%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Cardiac arrest | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Chest pain - cardiac | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Palpitations | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Sinus bradycardia | 5/132 (3.8%) | 0/1 (0%) | 3/113 (2.7%) | 0/12 (0%) | ||||
Sinus tachycardia | 3/132 (2.3%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Ventricular arrhythmia | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Endocrine disorders | ||||||||
Endocrine disorders-Other | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Eye disorders | ||||||||
Blurred vision | 5/132 (3.8%) | 0/1 (0%) | 2/113 (1.8%) | 1/12 (8.3%) | ||||
Eye disorders-Other | 1/132 (0.8%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Eye pain | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Floaters | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Watering eyes | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Gastrointestinal disorders | ||||||||
Abdominal pain | 7/132 (5.3%) | 0/1 (0%) | 2/113 (1.8%) | 2/12 (16.7%) | ||||
Anal hemorrhage | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Bloating | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Constipation | 52/132 (39.4%) | 1/1 (100%) | 7/113 (6.2%) | 1/12 (8.3%) | ||||
Diarrhea | 19/132 (14.4%) | 0/1 (0%) | 7/113 (6.2%) | 2/12 (16.7%) | ||||
Dry mouth | 12/132 (9.1%) | 0/1 (0%) | 2/113 (1.8%) | 2/12 (16.7%) | ||||
Dyspepsia | 15/132 (11.4%) | 0/1 (0%) | 2/113 (1.8%) | 1/12 (8.3%) | ||||
Dysphagia | 4/132 (3%) | 0/1 (0%) | 1/113 (0.9%) | 4/12 (33.3%) | ||||
Esophageal pain | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Esophagitis | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 1/12 (8.3%) | ||||
Flatulence | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Gastric ulcer | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Gastritis | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 1/12 (8.3%) | ||||
Gastroesophageal reflux disease | 7/132 (5.3%) | 0/1 (0%) | 5/113 (4.4%) | 0/12 (0%) | ||||
Gastrointestinal disorders-Other | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Gastrointestinal pain | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Hemorrhoidal hemorrhage | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Hemorrhoids | 3/132 (2.3%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Lower gastrointestinal hemorrhage | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Mucositis oral | 19/132 (14.4%) | 1/1 (100%) | 4/113 (3.5%) | 1/12 (8.3%) | ||||
Nausea | 60/132 (45.5%) | 1/1 (100%) | 11/113 (9.7%) | 2/12 (16.7%) | ||||
Oral pain | 4/132 (3%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Pancreatitis | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Stomach pain | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Toothache | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Vomiting | 13/132 (9.8%) | 1/1 (100%) | 2/113 (1.8%) | 0/12 (0%) | ||||
General disorders | ||||||||
Chills | 9/132 (6.8%) | 0/1 (0%) | 2/113 (1.8%) | 1/12 (8.3%) | ||||
Edema face | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Edema limbs | 11/132 (8.3%) | 1/1 (100%) | 4/113 (3.5%) | 0/12 (0%) | ||||
Facial pain | 3/132 (2.3%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Fatigue | 90/132 (68.2%) | 1/1 (100%) | 51/113 (45.1%) | 7/12 (58.3%) | ||||
Fever | 12/132 (9.1%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Flu like symptoms | 3/132 (2.3%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Gait disturbance | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
General disorders and admin site conditions - Other | 3/132 (2.3%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Infusion related reaction | 12/132 (9.1%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Injection site reaction | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Localized edema | 3/132 (2.3%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Multi-organ failure | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Non-cardiac chest pain | 3/132 (2.3%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Pain | 4/132 (3%) | 0/1 (0%) | 7/113 (6.2%) | 0/12 (0%) | ||||
Immune system disorders | ||||||||
Allergic reaction | 5/132 (3.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Autoimmune disorder | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Infections and infestations | ||||||||
Bronchial infection | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Catheter related infection | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Eye infection | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Gum infection | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Hepatitis viral | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Infections and infestations-Other | 0/132 (0%) | 0/1 (0%) | 3/113 (2.7%) | 0/12 (0%) | ||||
Lip infection | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Lung infection | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Mucosal infection | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Papulopustular rash | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Peripheral nerve infection | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Pharyngitis | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 1/12 (8.3%) | ||||
Rash pustular | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Sepsis | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Sinusitis | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Skin infection | 6/132 (4.5%) | 0/1 (0%) | 6/113 (5.3%) | 0/12 (0%) | ||||
Upper respiratory infection | 9/132 (6.8%) | 0/1 (0%) | 5/113 (4.4%) | 1/12 (8.3%) | ||||
Urinary tract infection | 10/132 (7.6%) | 0/1 (0%) | 1/113 (0.9%) | 1/12 (8.3%) | ||||
Vaginal infection | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Wound infection | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Injury, poisoning and procedural complications | ||||||||
Bruising | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Dermatitis radiation | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 2/12 (16.7%) | ||||
Fall | 2/132 (1.5%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Investigations | ||||||||
Alanine aminotransferase increased | 26/132 (19.7%) | 0/1 (0%) | 16/113 (14.2%) | 1/12 (8.3%) | ||||
Alkaline phosphatase increased | 5/132 (3.8%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Aspartate aminotransferase increased | 15/132 (11.4%) | 0/1 (0%) | 9/113 (8%) | 1/12 (8.3%) | ||||
Blood bilirubin increased | 3/132 (2.3%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
CD4 lymphocytes decreased | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Carbon monoxide diffusing capacity decreased | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Cardiac troponin I increased | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Cholesterol high | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Creatinine increased | 7/132 (5.3%) | 0/1 (0%) | 4/113 (3.5%) | 0/12 (0%) | ||||
Ejection fraction decreased | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Fibrinogen decreased | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Forced expiratory volume decreased | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Hemoglobin increased | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
INR increased | 3/132 (2.3%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Lymphocyte count decreased | 57/132 (43.2%) | 1/1 (100%) | 44/113 (38.9%) | 4/12 (33.3%) | ||||
Neutrophil count decreased | 46/132 (34.8%) | 0/1 (0%) | 16/113 (14.2%) | 5/12 (41.7%) | ||||
Platelet count decreased | 23/132 (17.4%) | 1/1 (100%) | 18/113 (15.9%) | 4/12 (33.3%) | ||||
Vital capacity abnormal | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Weight gain | 2/132 (1.5%) | 1/1 (100%) | 3/113 (2.7%) | 0/12 (0%) | ||||
Weight loss | 5/132 (3.8%) | 0/1 (0%) | 4/113 (3.5%) | 3/12 (25%) | ||||
White blood cell decreased | 49/132 (37.1%) | 1/1 (100%) | 34/113 (30.1%) | 5/12 (41.7%) | ||||
Metabolism and nutrition disorders | ||||||||
Anorexia | 13/132 (9.8%) | 1/1 (100%) | 5/113 (4.4%) | 4/12 (33.3%) | ||||
Dehydration | 8/132 (6.1%) | 0/1 (0%) | 1/113 (0.9%) | 1/12 (8.3%) | ||||
Glucose intolerance | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Hyperglycemia | 24/132 (18.2%) | 0/1 (0%) | 12/113 (10.6%) | 1/12 (8.3%) | ||||
Hyperkalemia | 0/132 (0%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Hypernatremia | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Hypertriglyceridemia | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Hyperuricemia | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Hypoalbuminemia | 19/132 (14.4%) | 1/1 (100%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Hypocalcemia | 11/132 (8.3%) | 0/1 (0%) | 4/113 (3.5%) | 0/12 (0%) | ||||
Hypoglycemia | 1/132 (0.8%) | 0/1 (0%) | 3/113 (2.7%) | 0/12 (0%) | ||||
Hypokalemia | 11/132 (8.3%) | 0/1 (0%) | 5/113 (4.4%) | 0/12 (0%) | ||||
Hypomagnesemia | 5/132 (3.8%) | 0/1 (0%) | 1/113 (0.9%) | 1/12 (8.3%) | ||||
Hyponatremia | 10/132 (7.6%) | 0/1 (0%) | 5/113 (4.4%) | 0/12 (0%) | ||||
Hypophosphatemia | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Musculoskeletal and connective tissue disorders | ||||||||
Arthralgia | 11/132 (8.3%) | 0/1 (0%) | 10/113 (8.8%) | 0/12 (0%) | ||||
Arthritis | 0/132 (0%) | 1/1 (100%) | 3/113 (2.7%) | 0/12 (0%) | ||||
Back pain | 9/132 (6.8%) | 0/1 (0%) | 4/113 (3.5%) | 2/12 (16.7%) | ||||
Bone pain | 21/132 (15.9%) | 1/1 (100%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Chest wall pain | 0/132 (0%) | 0/1 (0%) | 0/113 (0%) | 1/12 (8.3%) | ||||
Flank pain | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 1/12 (8.3%) | ||||
Generalized muscle weakness | 7/132 (5.3%) | 1/1 (100%) | 4/113 (3.5%) | 1/12 (8.3%) | ||||
Muscle weakness left-sided | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Muscle weakness lower limb | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Muscle weakness upper limb | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Musculoskeletal and connective tiss disorder - Other | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Myalgia | 8/132 (6.1%) | 1/1 (100%) | 3/113 (2.7%) | 2/12 (16.7%) | ||||
Neck pain | 9/132 (6.8%) | 0/1 (0%) | 1/113 (0.9%) | 1/12 (8.3%) | ||||
Pain in extremity | 3/132 (2.3%) | 0/1 (0%) | 7/113 (6.2%) | 1/12 (8.3%) | ||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Neoplasms benign, malignant and unspecified - Other | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Nervous system disorders | ||||||||
Ataxia | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Cognitive disturbance | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Concentration impairment | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Depressed level of consciousness | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Dizziness | 11/132 (8.3%) | 0/1 (0%) | 2/113 (1.8%) | 1/12 (8.3%) | ||||
Dysarthria | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Dysgeusia | 15/132 (11.4%) | 0/1 (0%) | 8/113 (7.1%) | 1/12 (8.3%) | ||||
Encephalopathy | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Headache | 17/132 (12.9%) | 1/1 (100%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Memory impairment | 2/132 (1.5%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Movements involuntary | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Nervous system disorders-Other | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 1/12 (8.3%) | ||||
Paresthesia | 4/132 (3%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Peripheral motor neuropathy | 5/132 (3.8%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Peripheral sensory neuropathy | 35/132 (26.5%) | 0/1 (0%) | 21/113 (18.6%) | 2/12 (16.7%) | ||||
Presyncope | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Seizure | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Stroke | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Syncope | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Psychiatric disorders | ||||||||
Agitation | 2/132 (1.5%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Anxiety | 12/132 (9.1%) | 1/1 (100%) | 1/113 (0.9%) | 1/12 (8.3%) | ||||
Confusion | 4/132 (3%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Delirium | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Depression | 3/132 (2.3%) | 1/1 (100%) | 0/113 (0%) | 1/12 (8.3%) | ||||
Hallucinations | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Insomnia | 22/132 (16.7%) | 0/1 (0%) | 3/113 (2.7%) | 2/12 (16.7%) | ||||
Renal and urinary disorders | ||||||||
Acute kidney injury | 3/132 (2.3%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Hematuria | 2/132 (1.5%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Proteinuria | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Renal and urinary disorders-Other | 2/132 (1.5%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Renal calculi | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Urinary frequency | 12/132 (9.1%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Urinary incontinence | 3/132 (2.3%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Urinary retention | 3/132 (2.3%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Urinary tract pain | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Urinary urgency | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Urine discoloration | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Reproductive system and breast disorders | ||||||||
Irregular menstruation | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Menorrhagia | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Pelvic pain | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Reproductive system and breast disorders - Other | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Respiratory, thoracic and mediastinal disorders | ||||||||
Allergic rhinitis | 1/132 (0.8%) | 0/1 (0%) | 2/113 (1.8%) | 1/12 (8.3%) | ||||
Atelectasis | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Cough | 21/132 (15.9%) | 1/1 (100%) | 10/113 (8.8%) | 3/12 (25%) | ||||
Dyspnea | 18/132 (13.6%) | 1/1 (100%) | 7/113 (6.2%) | 0/12 (0%) | ||||
Epistaxis | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Hiccups | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Hoarseness | 3/132 (2.3%) | 1/1 (100%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Hypoxia | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Laryngeal edema | 0/132 (0%) | 0/1 (0%) | 0/113 (0%) | 1/12 (8.3%) | ||||
Nasal congestion | 5/132 (3.8%) | 0/1 (0%) | 3/113 (2.7%) | 0/12 (0%) | ||||
Pleural effusion | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Postnasal drip | 1/132 (0.8%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Productive cough | 5/132 (3.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Resp, thoracic and mediastinal disorders - Other | 1/132 (0.8%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) | ||||
Sore throat | 9/132 (6.8%) | 0/1 (0%) | 2/113 (1.8%) | 1/12 (8.3%) | ||||
Voice alteration | 3/132 (2.3%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Skin and subcutaneous tissue disorders | ||||||||
Alopecia | 53/132 (40.2%) | 1/1 (100%) | 21/113 (18.6%) | 3/12 (25%) | ||||
Dry skin | 5/132 (3.8%) | 1/1 (100%) | 3/113 (2.7%) | 0/12 (0%) | ||||
Hyperhidrosis | 4/132 (3%) | 0/1 (0%) | 1/113 (0.9%) | 1/12 (8.3%) | ||||
Nail discoloration | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Nail ridging | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Pain of skin | 2/132 (1.5%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Periorbital edema | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Pruritus | 4/132 (3%) | 0/1 (0%) | 3/113 (2.7%) | 0/12 (0%) | ||||
Rash acneiform | 2/132 (1.5%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Rash maculo-papular | 9/132 (6.8%) | 1/1 (100%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Scalp pain | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Skin and subcutaneous tissue disorders - Other | 9/132 (6.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Skin ulceration | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Telangiectasia | 0/132 (0%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Vascular disorders | ||||||||
Hot flashes | 4/132 (3%) | 0/1 (0%) | 4/113 (3.5%) | 0/12 (0%) | ||||
Hypertension | 19/132 (14.4%) | 1/1 (100%) | 11/113 (9.7%) | 0/12 (0%) | ||||
Hypotension | 4/132 (3%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Lymphedema | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Phlebitis | 1/132 (0.8%) | 0/1 (0%) | 1/113 (0.9%) | 0/12 (0%) | ||||
Superficial thrombophlebitis | 1/132 (0.8%) | 0/1 (0%) | 0/113 (0%) | 0/12 (0%) | ||||
Thromboembolic event | 2/132 (1.5%) | 0/1 (0%) | 2/113 (1.8%) | 0/12 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Lymphoma Committee Statistician |
---|---|
Organization | SWOG Statistics and Data Management Center |
Phone | 206-667-4623 |
lymph@crab.org |
- CDR0000700624
- S1001
- U10CA032102