S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma

Sponsor
Southwest Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01359592
Collaborator
National Cancer Institute (NCI) (NIH)
159
240
2
141
0.7
0

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
  • Biological: rituximab
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: prednisone
  • Drug: vincristine sulfate
  • Other: R-CHOP regimen
  • Other: laboratory biomarker analysis
  • Radiation: fludeoxyglucose F 18
  • Radiation: selective external radiation therapy
  • Radiation: yttrium Y 90 ibritumomab tiuxetan
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

  • To evaluate PFS within the PET-positive (+) and PET-negative (-) subgroups of patients with newly diagnosed limited-stage DLBCL.

  • To evaluate toxicity of the protocol treatments in this patient population.

  • To evaluate the response probability in this patient population.

  • To evaluate overall survival in the overall population, and within the PET+ and PET- subgroups.

  • 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.

  • To describe outcomes in the subgroup of patients upstaged by PET/CT.

  • 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

Study Type:
Interventional
Actual Enrollment :
159 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Jun 3, 2020
Anticipated Study Completion Date :
Jun 1, 2023

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

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
  • Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL)

  • Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group

  • Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections

  • Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible

  • Patients must have non-bulky stage I or II disease by Ann Arbor classification

  • This staging excludes FDG-PET evaluation

  • 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

  • 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

  • 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

  • If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable

  • Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma

  • Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registration

  • Patients may have either measurable or evaluable limited-stage DLBCL

  • Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible

  • If patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form (Form #15187)

  • All measurable disease must be assessed within 28 days prior to registration

  • Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration

  • Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration

PATIENT CHARACTERISTICS:
  • Zubrod performance status 0-2

  • Absolute neutrophil count (ANC) ≥ 1,000/mm³

  • Platelet count ≥ 100,000/mm³

  • Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert syndrome)

  • Patients must not be pregnant or nursing

  • Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period

  • Patients must not be known to be HIV-positive

  • No other prior malignancy is allowed except for the following:

  • Adequately treated basal cell or squamous cell skin cancer

  • In situ cervical cancer

  • Adequately treated stage I or II cancer from which the patient is currently in complete remission

  • 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.
Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01359592
Other Study ID Numbers:
  • CDR0000700624
  • S1001
  • U10CA032102
First Posted:
May 25, 2011
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022

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

1. Primary Outcome
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%
2. Secondary Outcome
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
3. Secondary Outcome
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
4. Secondary Outcome
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%
5. Secondary Outcome
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
6. Secondary Outcome
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
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
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
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

[Not Specified]

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
Email lymph@crab.org
Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01359592
Other Study ID Numbers:
  • CDR0000700624
  • S1001
  • U10CA032102
First Posted:
May 25, 2011
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022