Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00301821
Collaborator
National Cancer Institute (NCI) (NIH)
107
162
1
110.9
0.7
0
Study Details
Study Description
Brief Summary
RATIONALE: Monoclonal antibodies, such as epratuzumab and 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:> Primary>
-
Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month, event-free survival, in patients with previously untreated stage II, III, or IV diffuse large B-cell lymphoma.>
-
Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.>
-
Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this regimen.>
-
Assess the safety of this treatment regimen.> Secondary>
-
Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen.> OUTLINE: This is a multicenter study.> Patients receive epratuzumab IV over 1 hour on day 1, rituximab IV over 4-8 hours on day 1 or days 1 and 2, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 or 2, and oral prednisone on days 1-5 or 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.> After completion of study treatment, patients are followed periodically for up to 5 years.> PROJECTED ACCRUAL: A total of 86 patients will be accrued for this study.>
Study Design
Study Type:
Interventional
Actual Enrollment
:
107 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
Study Start Date
:
Jan 1, 2006
Actual Primary Completion Date
:
Oct 1, 2008
Actual Study Completion Date
:
Apr 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Epratuzumab + Rituximab + CHOP One arm open label. |
Biological: epratuzumab
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
|
Outcome Measures
Primary Outcome Measures
- Event-free Survival After 12 Months [From Baseline to 12 months]
The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).
Secondary Outcome Measures
- Overall Survival [time from study entry to 36 months]
Percentage of participants alive at different time points
- Progression-free Survival (PFS) [the time from study entry to 36 months]
Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
- Overall Response Rate (ORR) [Baseline to first 6 cycles of treatment]
Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment). Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
-
Histologically confirmed diffuse large B-cell lymphoma
-
B-cell phenotype (CD20+) as determined by immunohistochemistry (IHC) or flow cytometry
-
Stage II, III, or IV disease
-
CD22+ tumor by IHC*
NOTE: *CD22 status may be determined after study enrollment
-
Measurable disease, defined as at least 1 lesion ≥ 1.5 cm by CT scan or physical exam
-
No relapsed or refractory non-Hodgkin's lymphoma
-
No history of transformed lymphoma
-
No CNS lymphoma
-
CNS symptoms or bone marrow or sinus involvement must have absence of CNS lymphoma confirmed by lumbar puncture
PATIENT CHARACTERISTICS:
-
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
-
For patients with ECOG PS 3, the PS must be disease related
-
Absolute neutrophil count ≥ 1,500/mm^3
-
Platelet count ≥ 100,000/mm^3
-
Total bilirubin ≤ 2 mg/dL (if total bilirubin > 2 mg/dL, direct bilirubin should be within normal limits)
-
AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if there is liver involvement)
-
Creatinine ≤ 2 times ULN
-
Life expectancy ≥ 12 weeks
-
Negative pregnancy test
-
Not pregnant or nursing
-
Fertile patients must use effective contraception during and for 12 months after completion of study treatment
-
No active serious infection requiring antibiotics
-
No New York Heart Association class III or IV heart disease
-
No other primary malignancy within the past 5 years, except for squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or previously treated prostate cancer with a stable prostate-specific antigen
-
No known HIV positivity
-
No known hepatitis B or C infection
-
Ejection fraction ≥ 45% by MUGA or echocardiogram (required if patients has a history of heart disease or is ≥ 50 years old)
-
Willing to provide blood and tissue samples for mandatory translational research component of study
PRIOR CONCURRENT THERAPY:
-
No prior therapy for diffuse large B-cell lymphoma, including the following:
-
Chemotherapy
-
Immunotherapy
-
Biologic therapy
-
Radiotherapy
-
Prior short course (≤ 14 days) of corticosteroids allowed
-
Prior splenectomy allowed
-
No prior pelvic irradiation
-
No other concurrent investigational agents
-
No concurrent chemotherapy, immunotherapy, or radiotherapy
-
No concurrent enrollment on another treatment study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic Scottsdale | Scottsdale | Arizona | United States | 85259-5499 |
| 2 | Aurora Presbyterian Hospital | Aurora | Colorado | United States | 80012 |
| 3 | Boulder Community Hospital | Boulder | Colorado | United States | 80301-9019 |
| 4 | Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado | United States | 80933 |
| 5 | Porter Adventist Hospital | Denver | Colorado | United States | 80210 |
| 6 | Presbyterian - St. Luke's Medical Center | Denver | Colorado | United States | 80218 |
| 7 | St. Joseph Hospital | Denver | Colorado | United States | 80218 |
| 8 | Rose Medical Center | Denver | Colorado | United States | 80220 |
| 9 | CCOP - Colorado Cancer Research Program | Denver | Colorado | United States | 80224-2522 |
| 10 | Swedish Medical Center | Englewood | Colorado | United States | 80110 |
| 11 | Front Range Cancer Specialists | Fort Collins | Colorado | United States | 80524 |
| 12 | St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado | United States | 81502 |
| 13 | Sky Ridge Medical Center | Lone Tree | Colorado | United States | 80124 |
| 14 | Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado | United States | 80502 |
| 15 | St. Mary - Corwin Regional Medical Center | Pueblo | Colorado | United States | 81004 |
| 16 | North Suburban Medical Center | Thornton | Colorado | United States | 80229 |
| 17 | Exempla Lutheran Medical Center | Wheat Ridge | Colorado | United States | 80033 |
| 18 | Mayo Clinic - Jacksonville | Jacksonville | Florida | United States | 32224 |
| 19 | Rush-Copley Cancer Care Center | Aurora | Illinois | United States | 60507 |
| 20 | St. Joseph Medical Center | Bloomington | Illinois | United States | 61701 |
| 21 | Graham Hospital | Canton | Illinois | United States | 61520 |
| 22 | Memorial Hospital | Carthage | Illinois | United States | 62321 |
| 23 | Eureka Community Hospital | Eureka | Illinois | United States | 61530 |
| 24 | Galesburg Clinic | Galesburg | Illinois | United States | 61401 |
| 25 | Galesburg Cottage Hospital | Galesburg | Illinois | United States | 61401 |
| 26 | Mason District Hospital | Havana | Illinois | United States | 62644 |
| 27 | Hopedale Medical Complex | Hopedale | Illinois | United States | 61747 |
| 28 | Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | United States | 60435 |
| 29 | Kewanee Hospital | Kewanee | Illinois | United States | 61443 |
| 30 | McDonough District Hospital | Macomb | Illinois | United States | 61455 |
| 31 | Trinity Medical Center - East | Moline | Illinois | United States | 61265 |
| 32 | Moline | Illinois | United States | 61265 | |
| 33 | BroMenn Regional Medical Center | Normal | Illinois | United States | 61761 |
| 34 | Community Cancer Center | Normal | Illinois | United States | 61761 |
| 35 | Community Hospital of Ottawa | Ottawa | Illinois | United States | 61350 |
| 36 | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | United States | 61350 |
| 37 | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | United States | 61554 |
| 38 | Proctor Hospital | Peoria | Illinois | United States | 61614 |
| 39 | CCOP - Illinois Oncology Research Association | Peoria | Illinois | United States | 61615 |
| 40 | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | United States | 61615 |
| 41 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
| 42 | OSF St. Francis Medical Center | Peoria | Illinois | United States | 61637 |
| 43 | Illinois Valley Community Hospital | Peru | Illinois | United States | 61354 |
| 44 | Perry Memorial Hospital | Princeton | Illinois | United States | 61356 |
| 45 | St. Margaret's Hospital | Spring Valley | Illinois | United States | 61362 |
| 46 | Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
| 47 | CCOP - Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 48 | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | United States | 46107 |
| 49 | Saint Anthony Memorial Health Centers | Michigan City | Indiana | United States | 46360 |
| 50 | Reid Hospital & Health Care Services, Incorporated | Richmond | Indiana | United States | 47374 |
| 51 | McFarland Clinic, PC | Ames | Iowa | United States | 50010 |
| 52 | Mercy Capitol Hospital | Des Moines | Iowa | United States | 50307 |
| 53 | CCOP - Iowa Oncology Research Association | Des Moines | Iowa | United States | 50309 |
| 54 | John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
| 55 | Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | United States | 50309 |
| 56 | Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | United States | 50314 |
| 57 | Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
| 58 | John Stoddard Cancer Center | Des Moines | Iowa | United States | 50316-2301 |
| 59 | Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City | Iowa | United States | 50401 |
| 60 | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | United States | 51101 |
| 61 | Mercy Medical Center - Sioux City | Sioux City | Iowa | United States | 51104 |
| 62 | St. Luke's Regional Medical Center | Sioux City | Iowa | United States | 51104 |
| 63 | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | United States | 66720 |
| 64 | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | United States | 67801 |
| 65 | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | United States | 67042 |
| 66 | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | United States | 67068 |
| 67 | Southwest Medical Center | Liberal | Kansas | United States | 67901 |
| 68 | Cancer Center of Kansas, PA - Newton | Newton | Kansas | United States | 67114 |
| 69 | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | United States | 67357 |
| 70 | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | United States | 67124 |
| 71 | Cancer Center of Kansas, PA - Salina | Salina | Kansas | United States | 67042 |
| 72 | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | United States | 67152 |
| 73 | Associates in Womens Health, PA - North Review | Wichita | Kansas | United States | 67203 |
| 74 | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | United States | 67208 |
| 75 | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | United States | 67214 |
| 76 | CCOP - Wichita | Wichita | Kansas | United States | 67214 |
| 77 | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
| 78 | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | United States | 67156 |
| 79 | Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | United States | 49221 |
| 80 | Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan | United States | 48144 |
| 81 | Community Cancer Center of Monroe | Monroe | Michigan | United States | 48162 |
| 82 | Mercy Memorial Hospital - Monroe | Monroe | Michigan | United States | 48162 |
| 83 | Alexandria | Minnesota | United States | 56308 | |
| 84 | MeritCare Bemidji | Bemidji | Minnesota | United States | 56601 |
| 85 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
| 86 | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
| 87 | Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | United States | 55805-1983 |
| 88 | CCOP - Duluth | Duluth | Minnesota | United States | 55805 |
| 89 | Miller - Dwan Medical Center | Duluth | Minnesota | United States | 55805 |
| 90 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
| 91 | Fergus Falls | Minnesota | United States | 56537 | |
| 92 | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | United States | 55432 |
| 93 | Hutchinson Area Health Care | Hutchinson | Minnesota | United States | 55350 |
| 94 | Meeker County Memorial Hospital | Litchfield | Minnesota | United States | 55355 |
| 95 | HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | United States | 55109 |
| 96 | Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | United States | 55109 |
| 97 | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 98 | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55415 |
| 99 | Chippewa County - Montevideo Hospital and Medical Center | Montevideo | Minnesota | United States | 56265 |
| 100 | Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | United States | 55422-2900 |
| 101 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
| 102 | CentraCare Clinic - River Campus | Saint Cloud | Minnesota | United States | 56303 |
| 103 | Coborn Cancer Center | Saint Cloud | Minnesota | United States | 56303 |
| 104 | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | United States | 55416 |
| 105 | Park Nicollet Cancer Center | Saint Louis Park | Minnesota | United States | 55416 |
| 106 | Regions Hospital Cancer Care Center | Saint Paul | Minnesota | United States | 55101 |
| 107 | HealthEast Cancer Care at St. Joseph's Hospital | Saint Paul | Minnesota | United States | 55102 |
| 108 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
| 109 | St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | United States | 55379 |
| 110 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
| 111 | HealthEast Cancer Care at Woodwinds Health Campus | Woodbury | Minnesota | United States | 55125 |
| 112 | Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | United States | 55125 |
| 113 | Cancer Resource Center - Lincoln | Lincoln | Nebraska | United States | 68510 |
| 114 | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | United States | 68106 |
| 115 | Immanuel Medical Center | Omaha | Nebraska | United States | 68122 |
| 116 | Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | United States | 68124 |
| 117 | Creighton University Medical Center | Omaha | Nebraska | United States | 68131-2197 |
| 118 | Rutherford Hospital | Rutherfordton | North Carolina | United States | 28139 |
| 119 | Bismarck Cancer Center | Bismarck | North Dakota | United States | 58501 |
| 120 | Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | United States | 58501 |
| 121 | Mid Dakota Clinic, PC | Bismarck | North Dakota | United States | 58501 |
| 122 | St. Alexius Medical Center Cancer Center | Bismarck | North Dakota | United States | 58502 |
| 123 | CCOP - MeritCare Hospital | Fargo | North Dakota | United States | 58122 |
| 124 | MeritCare Broadway | Fargo | North Dakota | United States | 58122 |
| 125 | Wood County Oncology Center | Bowling Green | Ohio | United States | 43402 |
| 126 | Grandview Hospital | Dayton | Ohio | United States | 45405 |
| 127 | Good Samaritan Hospital | Dayton | Ohio | United States | 45406 |
| 128 | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
| 129 | Samaritan North Cancer Care Center | Dayton | Ohio | United States | 45415 |
| 130 | Veterans Affairs Medical Center - Dayton | Dayton | Ohio | United States | 45428 |
| 131 | CCOP - Dayton | Dayton | Ohio | United States | 45429 |
| 132 | Blanchard Valley Medical Associates | Findlay | Ohio | United States | 45840 |
| 133 | Fremont Memorial Hospital | Fremont | Ohio | United States | 43420 |
| 134 | Charles F. Kettering Memorial Hospital | Kettering | Ohio | United States | 45429 |
| 135 | Lima Memorial Hospital | Lima | Ohio | United States | 45804 |
| 136 | Northwest Ohio Oncology Center | Maumee | Ohio | United States | 43537 |
| 137 | St. Luke's Hospital | Maumee | Ohio | United States | 43537 |
| 138 | Middletown Regional Hospital | Middletown | Ohio | United States | 45044 |
| 139 | St. Charles Mercy Hospital | Oregon | Ohio | United States | 43616 |
| 140 | Toledo Clinic - Oregon | Oregon | Ohio | United States | 43616 |
| 141 | Firelands Regional Medical Center | Sandusky | Ohio | United States | 44870 |
| 142 | North Coast Cancer Care, Incorporated | Sandusky | Ohio | United States | 44870 |
| 143 | Flower Hospital Cancer Center | Sylvania | Ohio | United States | 43560 |
| 144 | Mercy Hospital of Tiffin | Tiffin | Ohio | United States | 44883 |
| 145 | Toledo Hospital | Toledo | Ohio | United States | 43606 |
| 146 | St. Vincent Mercy Medical Center | Toledo | Ohio | United States | 43608 |
| 147 | Medical University of Ohio Cancer Center | Toledo | Ohio | United States | 43614 |
| 148 | CCOP - Toledo Community Hospital | Toledo | Ohio | United States | 43617 |
| 149 | Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | United States | 43623 |
| 150 | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | United States | 45373-1300 |
| 151 | Fulton County Health Center | Wauseon | Ohio | United States | 43567 |
| 152 | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | United States | 45385 |
| 153 | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | United States | 74136 |
| 154 | Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | United States | 18105 |
| 155 | AnMed Cancer Center | Anderson | South Carolina | United States | 29621 |
| 156 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
| 157 | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | United States | 29303 |
| 158 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
| 159 | Medical X-Ray Center, PC | Sioux Falls | South Dakota | United States | 57105 |
| 160 | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | United States | 57117-5039 |
| 161 | Hematology-Oncology Associates of Fredericksburg, Incorporated | Fredericksburg | Virginia | United States | 22401 |
| 162 | Franciscan Skemp Healthcare - La Crosse Campus | La Crosse | Wisconsin | United States | 54601 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Ivana Micallef, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00301821
Other Study ID Numbers:
- NCCTG-N0489
- NCI-2012-02685
- CDR0000459932
First Posted:
Mar 13, 2006
Last Update Posted:
Oct 9, 2019
Last Verified:
Oct 1, 2019
Keywords provided by Alliance for Clinical Trials in Oncology
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | For this study 107 patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) were enrolled. Twenty-six (24%) patients were declared ineligible based on pathology review; 1 patient canceled before beginning treatment. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Epratuzumab + Rituximab + CHOP |
|---|---|
| Arm/Group Description | One arm open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate |
| Period Title: Overall Study | |
| STARTED | 107 |
| COMPLETED | 81 |
| NOT COMPLETED | 26 |
Baseline Characteristics
| Arm/Group Title | Epratuzumab + Rituximab + CHOP |
|---|---|
| Arm/Group Description | One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate. |
| Overall Participants | 107 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
62
|
| Sex: Female, Male (Count of Participants) | |
| Female |
48
44.9%
|
| Male |
59
55.1%
|
| Region of Enrollment (participants) [Number] | |
| United States |
107
100%
|
Outcome Measures
| Title | Event-free Survival After 12 Months |
|---|---|
| Description | The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12). |
| Time Frame | From Baseline to 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| First 76 eligible participants were included in this analysis. |
| Arm/Group Title | Epratuzumab + Rituximab + CHOP |
|---|---|
| Arm/Group Description | One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate. |
| Measure Participants | 76 |
| Number [percentage of participants] |
78
72.9%
|
| Title | Overall Survival |
|---|---|
| Description | Percentage of participants alive at different time points |
| Time Frame | time from study entry to 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent To Treat (All Patients) |
| Arm/Group Title | Epratuzumab + Rituximab + CHOP |
|---|---|
| Arm/Group Description | One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate. |
| Measure Participants | 107 |
| Overall Survival at 12 months |
89
83.2%
|
| Overall Survival at 24 months |
81
75.7%
|
| Overall Survival at 36 months |
80
74.8%
|
| Title | Progression-free Survival (PFS) |
|---|---|
| Description | Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance. |
| Time Frame | the time from study entry to 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent To Treat (All Patients) |
| Arm/Group Title | Epratuzumab + Rituximab + CHOP |
|---|---|
| Arm/Group Description | One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate. |
| Measure Participants | 107 |
| Progression Free Survival at 12 months |
85
79.4%
|
| Progression Free Survival at 24 months |
77
72%
|
| Progression Free Survival at 36 months |
76
71%
|
| Title | Overall Response Rate (ORR) |
|---|---|
| Description | Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment). Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance. |
| Time Frame | Baseline to first 6 cycles of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Out of the 107 patients enrolled, Twenty-five patients were declared ineligible based on pathology review; 1 patient canceled before beginning treatment. |
| Arm/Group Title | Epratuzumab + Rituximab + CHOP |
|---|---|
| Arm/Group Description | One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate. |
| Measure Participants | 81 |
| Number [percentage of participants] |
95
88.8%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | One patient canceled before beginning treatment. | |
| Arm/Group Title | Epratuzumab + Rituximab + CHOP | |
| Arm/Group Description | One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate. | |
All Cause Mortality |
||
| Epratuzumab + Rituximab + CHOP | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Epratuzumab + Rituximab + CHOP | ||
| Affected / at Risk (%) | # Events | |
| Total | 72/106 (67.9%) | |
| Blood and lymphatic system disorders | ||
| Febrile neutropenia | 12/106 (11.3%) | 16 |
| Hemoglobin decreased | 7/106 (6.6%) | 8 |
| Cardiac disorders | ||
| Atrial fibrillation | 1/106 (0.9%) | 1 |
| Left ventricular failure | 1/106 (0.9%) | 1 |
| Sinus tachycardia | 2/106 (1.9%) | 2 |
| Gastrointestinal disorders | ||
| Cecal hemorrhage | 1/106 (0.9%) | 1 |
| Diarrhea | 2/106 (1.9%) | 2 |
| Gastic fistula | 1/106 (0.9%) | 1 |
| Ileal hemorrhage | 1/106 (0.9%) | 1 |
| Lower gastrointestinal hemorrhage | 1/106 (0.9%) | 1 |
| Nausea | 1/106 (0.9%) | 1 |
| Small intestinal obstruction | 1/106 (0.9%) | 2 |
| Stomach pain | 1/106 (0.9%) | 1 |
| Vomiting | 2/106 (1.9%) | 2 |
| General disorders | ||
| Chest pain | 1/106 (0.9%) | 1 |
| Fatigue | 3/106 (2.8%) | 3 |
| Fever | 1/106 (0.9%) | 1 |
| Immune system disorders | ||
| Cytokine release syndrome | 1/106 (0.9%) | 1 |
| Infections and infestations | ||
| Abdominal infection | 1/106 (0.9%) | 1 |
| Bladder infection | 1/106 (0.9%) | 1 |
| Eye infection | 1/106 (0.9%) | 1 |
| Peritoneal infection | 1/106 (0.9%) | 1 |
| Pneumonia | 6/106 (5.7%) | 6 |
| Sepsis | 1/106 (0.9%) | 1 |
| Skin infection | 1/106 (0.9%) | 1 |
| Injury, poisoning and procedural complications | ||
| Vascular access complication | 1/106 (0.9%) | 1 |
| Investigations | ||
| Leukocyte count decreased | 62/106 (58.5%) | 136 |
| Lymphocyte count decreased | 2/106 (1.9%) | 3 |
| Neutrophil count decreased | 67/106 (63.2%) | 149 |
| Platelet count decreased | 9/106 (8.5%) | 10 |
| Metabolism and nutrition disorders | ||
| Anorexia | 1/106 (0.9%) | 1 |
| Blood glucose increased | 2/106 (1.9%) | 4 |
| Dehydration | 3/106 (2.8%) | 3 |
| Serum potassium decreased | 2/106 (1.9%) | 2 |
| Serum sodium decreased | 2/106 (1.9%) | 2 |
| Tumor lysis syndrome | 1/106 (0.9%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 1/106 (0.9%) | 1 |
| Muscle weakness | 1/106 (0.9%) | 1 |
| Nervous system disorders | ||
| Ischemia cerebrovascular | 1/106 (0.9%) | 1 |
| Syncope | 1/106 (0.9%) | 1 |
| Psychiatric disorders | ||
| Confusion | 2/106 (1.9%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnea | 4/106 (3.8%) | 4 |
| Hypoxia | 4/106 (3.8%) | 4 |
| Pleural effusion | 1/106 (0.9%) | 1 |
| Pneumonitis | 2/106 (1.9%) | 2 |
| Respiratory disorder | 1/106 (0.9%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Erythema multiforme | 1/106 (0.9%) | 1 |
| Vascular disorders | ||
| Hypotension | 2/106 (1.9%) | 2 |
| Thrombosis | 5/106 (4.7%) | 5 |
Other (Not Including Serious) Adverse Events |
||
| Epratuzumab + Rituximab + CHOP | ||
| Affected / at Risk (%) | # Events | |
| Total | 105/106 (99.1%) | |
| Blood and lymphatic system disorders | ||
| Febrile neutropenia | 8/106 (7.5%) | 9 |
| Hemoglobin decreased | 30/106 (28.3%) | 68 |
| Cardiac disorders | ||
| Atrial fibrillation | 1/106 (0.9%) | 1 |
| Left ventricular dysfunction | 1/106 (0.9%) | 1 |
| Left ventricular failure | 1/106 (0.9%) | 1 |
| Myocardial ischemia | 1/106 (0.9%) | 1 |
| Sinus tachycardia | 1/106 (0.9%) | 1 |
| Ear and labyrinth disorders | ||
| Hearing impaired | 1/106 (0.9%) | 1 |
| Endocrine disorders | ||
| Hypothyroidism | 1/106 (0.9%) | 1 |
| Eye disorders | ||
| Vision blurred | 1/106 (0.9%) | 1 |
| Gastrointestinal disorders | ||
| Abdominal distension | 1/106 (0.9%) | 1 |
| Abdominal pain | 3/106 (2.8%) | 4 |
| Constipation | 6/106 (5.7%) | 7 |
| Diarrhea | 9/106 (8.5%) | 12 |
| Dry mouth | 1/106 (0.9%) | 1 |
| Dyspepsia | 4/106 (3.8%) | 6 |
| Dysphagia | 1/106 (0.9%) | 1 |
| Esophageal hemorrhage | 1/106 (0.9%) | 1 |
| Flatulence | 1/106 (0.9%) | 6 |
| Ileus | 1/106 (0.9%) | 1 |
| Lower gastrointestinal hemorrhage | 1/106 (0.9%) | 1 |
| Mucositis oral | 9/106 (8.5%) | 11 |
| Nausea | 12/106 (11.3%) | 17 |
| Oral pain | 1/106 (0.9%) | 1 |
| Small intestinal obstruction | 1/106 (0.9%) | 1 |
| Vomiting | 28/106 (26.4%) | 47 |
| General disorders | ||
| Chest pain | 1/106 (0.9%) | 1 |
| Edema limbs | 2/106 (1.9%) | 2 |
| Fatigue | 36/106 (34%) | 89 |
| Fever | 2/106 (1.9%) | 2 |
| General symptom | 2/106 (1.9%) | 2 |
| Hepatobiliary disorders | ||
| Cholecystitis | 1/106 (0.9%) | 1 |
| Immune system disorders | ||
| Cytokine release syndrome | 14/106 (13.2%) | 14 |
| Hypersensitivity | 2/106 (1.9%) | 2 |
| Infections and infestations | ||
| Appendicitis | 1/106 (0.9%) | 1 |
| Appendicitis perforated | 1/106 (0.9%) | 1 |
| Bladder infection | 2/106 (1.9%) | 2 |
| Conjunctivitis infective | 1/106 (0.9%) | 1 |
| Gastric infection | 1/106 (0.9%) | 1 |
| Gingival infection | 3/106 (2.8%) | 4 |
| Infection | 1/106 (0.9%) | 1 |
| Mucosal infection | 1/106 (0.9%) | 1 |
| Pneumonia | 4/106 (3.8%) | 4 |
| Skin infection | 3/106 (2.8%) | 3 |
| Tooth infection | 1/106 (0.9%) | 1 |
| Upper respiratory infection | 3/106 (2.8%) | 3 |
| Urinary tract infection | 1/106 (0.9%) | 1 |
| Viral hepatitis | 1/106 (0.9%) | 1 |
| Injury, poisoning and procedural complications | ||
| Vascular access complication | 1/106 (0.9%) | 1 |
| Investigations | ||
| Activated partial thromboplastin time prolonged | 1/106 (0.9%) | 1 |
| Alanine aminotransferase increased | 1/106 (0.9%) | 1 |
| Alkaline phosphatase increased | 1/106 (0.9%) | 2 |
| Aspartate aminotransferase increased | 2/106 (1.9%) | 3 |
| Blood bilirubin increased | 1/106 (0.9%) | 1 |
| Creatinine increased | 2/106 (1.9%) | 2 |
| Leukocyte count decreased | 88/106 (83%) | 326 |
| Lymphocyte count decreased | 7/106 (6.6%) | 23 |
| Neutrophil count decreased | 78/106 (73.6%) | 200 |
| Platelet count decreased | 71/106 (67%) | 260 |
| Weight gain | 3/106 (2.8%) | 10 |
| Weight loss | 4/106 (3.8%) | 7 |
| Metabolism and nutrition disorders | ||
| Anorexia | 9/106 (8.5%) | 12 |
| Blood glucose increased | 18/106 (17%) | 32 |
| Dehydration | 5/106 (4.7%) | 5 |
| Serum albumin decreased | 3/106 (2.8%) | 3 |
| Serum calcium decreased | 6/106 (5.7%) | 6 |
| Serum glucose decreased | 1/106 (0.9%) | 1 |
| Serum phosphate decreased | 1/106 (0.9%) | 1 |
| Serum potassium decreased | 1/106 (0.9%) | 1 |
| Serum sodium decreased | 1/106 (0.9%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 3/106 (2.8%) | 3 |
| Back pain | 2/106 (1.9%) | 2 |
| Bone pain | 4/106 (3.8%) | 4 |
| Muscle weakness | 2/106 (1.9%) | 2 |
| Muscle weakness lower limb | 1/106 (0.9%) | 2 |
| Muscle weakness right-sided | 1/106 (0.9%) | 1 |
| Myalgia | 4/106 (3.8%) | 4 |
| Pain in extremity | 1/106 (0.9%) | 1 |
| Trismus | 1/106 (0.9%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Myelodysplasia | 1/106 (0.9%) | 8 |
| Tumor pain | 1/106 (0.9%) | 1 |
| Nervous system disorders | ||
| Dysgeusia | 3/106 (2.8%) | 8 |
| Headache | 1/106 (0.9%) | 2 |
| Memory impairment | 1/106 (0.9%) | 2 |
| Neurological disorder NOS | 1/106 (0.9%) | 1 |
| Peripheral motor neuropathy | 3/106 (2.8%) | 3 |
| Peripheral sensory neuropathy | 50/106 (47.2%) | 199 |
| Syncope vasovagal | 1/106 (0.9%) | 1 |
| Taste alteration | 1/106 (0.9%) | 2 |
| Tremor | 1/106 (0.9%) | 1 |
| Psychiatric disorders | ||
| Agitation | 1/106 (0.9%) | 1 |
| Depression | 3/106 (2.8%) | 4 |
| Insomnia | 4/106 (3.8%) | 4 |
| Renal and urinary disorders | ||
| Bladder obstruction | 1/106 (0.9%) | 1 |
| Cystitis | 1/106 (0.9%) | 2 |
| Kidney pain | 1/106 (0.9%) | 1 |
| Urinary frequency | 1/106 (0.9%) | 1 |
| Urinary incontinence | 2/106 (1.9%) | 2 |
| Reproductive system and breast disorders | ||
| Prostatic obstruction | 1/106 (0.9%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Allergic rhinitis | 1/106 (0.9%) | 1 |
| Bronchospasm | 1/106 (0.9%) | 1 |
| Cough | 1/106 (0.9%) | 1 |
| Dyspnea | 7/106 (6.6%) | 7 |
| Hiccups | 1/106 (0.9%) | 1 |
| Hypoxia | 3/106 (2.8%) | 3 |
| Pharyngolaryngeal pain | 1/106 (0.9%) | 1 |
| Pleural effusion | 3/106 (2.8%) | 3 |
| Pneumonitis | 3/106 (2.8%) | 3 |
| Respiratory disorder | 1/106 (0.9%) | 1 |
| Voice alteration | 1/106 (0.9%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Alopecia | 40/106 (37.7%) | 150 |
| Hand-and-foot syndrome | 1/106 (0.9%) | 1 |
| Pruritus | 1/106 (0.9%) | 1 |
| Skin disorder | 1/106 (0.9%) | 2 |
| Sweating | 2/106 (1.9%) | 4 |
| Vascular disorders | ||
| Hypertension | 1/106 (0.9%) | 1 |
| Hypotension | 3/106 (2.8%) | 3 |
| Thrombosis | 3/106 (2.8%) | 3 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Ivana N. M. Micallef, M.D. |
|---|---|
| Organization | Mayo Clinic |
| Phone | 507-284-4642 |
| micallef.ivana@mayo.edu |
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00301821
Other Study ID Numbers:
- NCCTG-N0489
- NCI-2012-02685
- CDR0000459932
First Posted:
Mar 13, 2006
Last Update Posted:
Oct 9, 2019
Last Verified:
Oct 1, 2019