Lymphoma
Conditions
Keywords
stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma
Brief summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES: * Compare the progression-free survival and overall survival of patients with newly diagnosed follicular non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with or without either rituximab or iodine I 131 tositumomab (monoclonal antibody anti-B1). (CHOP chemotherapy alone arm closed to accrual as of 12/15/02) * Compare the response rate of these patients treated with these regimens. * Compare the toxic effects of these regimens in these patients. * Compare the molecular remission rates of this patient population treated with these regimens. * Determine the incidence and time to development of human anti-mouse antibody positivity. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether microglobulin is greater than upper limit of normal (yes vs no). Patients are randomized to 1 of 3 treatment arms. (Arm I closed to accrual as of 12/15/02) * Arm I (CHOP only): Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02) * Arm II (CHOP + rituximab): Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141. * Arm III (CHOP + tositumomab): Patients receive chemotherapy as in arm I and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141. Patients are followed on day 200, at 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 500 patients (250 per treatment arm) will be accrued for this study within 5.5 years. (Arm I closed to accrual as of 12/15/02)
Interventions
BIOLOGICALrituximab
Given IV
DRUGcyclophosphamide
Given IV
DRUGdoxorubicin
Given IV
DRUGprednisone
Given orally
DRUGvincristine
Given IV
RADIATIONtositumomab
Given IV
Sponsors
SWOG Cancer Research Network
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed previously untreated bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma * Grade I-III disease * Cluster of differentiation antigen 20 (CD20) antigen positive * Fewer than 5,000/mm\^3 circulating lymphoid cells on a white blood cell (WBC) differential count * Bidimensionally measurable disease * Bone marrow aspiration and biopsy within the past 42 days * No clinical evidence of central nervous system (CNS) involvement by lymphoma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics * Granulocyte count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No impaired cardiac status, including: * Severe coronary artery disease * Cardiomyopathy * Congestive heart failure * Serious arrhythmia * Ejection fraction at least lower limit of normal by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram for questionable cardiac history Other: * No hypersensitivity to iodine * Not pregnant or nursing * Fertile patients must use effective contraception during and for 6 months after study participation * HIV negative * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior monoclonal antibodies for cancer Chemotherapy: * No prior chemotherapy for lymphoma * Prior prednisone for non-lymphoma related illnesses allowed Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for lymphoma Surgery: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival at 2 Years | 0-2 years | Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date |
| Progression-free Survival at 5 Years | 0-5 years | Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date |
| Overall Survival at 2 Years | 0-2 years | Measured from date of registration to date of death due to any cause |
| Overall Survival at 5 Years | 0-5 years | Measured from date of registration to date of death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response (Confirmed and Unconfirmed Complete and Partial Responses) | Assessed 200 days and 365 days after initiation of therapy and then every 6 months until death | Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. 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. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. 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. |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal |
Countries
United States
Contacts
STUDY_CHAIROliver W. Press, MD, PhD
Fred Hutchinson Cancer Center
STUDY_CHAIRMyron S. Czuczman, MD
Roswell Park Cancer Institute
STUDY_CHAIRSandra J. Horning, MD
Stanford University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CHOP + Rituximab Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141 | 267 |
| CHOP + Tositumomab Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141 | 265 |
| CHOP Only Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02) | 14 |
| Total | 546 |
Baseline characteristics
| Characteristic | CHOP + Rituximab | CHOP + Tositumomab | CHOP Only | Total |
|---|---|---|---|---|
| Age, Continuous | 54.5 years | 53.3 years | 54.5 years | 54 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 10 Participants | 0 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 232 Participants | 220 Participants | 14 Participants | 466 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 29 Participants | 35 Participants | 0 Participants | 64 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 3 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 10 Participants | 0 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 12 Participants | 0 Participants | 20 Participants |
| Race (NIH/OMB) White | 241 Participants | 238 Participants | 13 Participants | 492 Participants |
| Sex: Female, Male Female | 125 Participants | 118 Participants | 4 Participants | 247 Participants |
| Sex: Female, Male Male | 142 Participants | 147 Participants | 10 Participants | 299 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| other Total, other adverse events | 13 / 13 | 262 / 263 | 261 / 263 |
| serious Total, serious adverse events | 0 / 13 | 3 / 263 | 16 / 263 |
Outcome results
Primary
Overall Survival at 2 Years
Measured from date of registration to date of death due to any cause
Time frame: 0-2 years
Population: All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHOP + Rituximab | Overall Survival at 2 Years | 97 percentage of participants |
| CHOP + Tositumomab | Overall Survival at 2 Years | 93 percentage of participants |
p-value: 0.0895% CI: [0.95, 2.54]Regression, Cox
Primary
Overall Survival at 5 Years
Measured from date of registration to date of death due to any cause
Time frame: 0-5 years
Population: All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHOP + Rituximab | Overall Survival at 5 Years | 92 percentage of participants |
| CHOP + Tositumomab | Overall Survival at 5 Years | 86 percentage of participants |
Primary
Progression-free Survival at 2 Years
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date
Time frame: 0-2 years
Population: All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHOP + Rituximab | Progression-free Survival at 2 Years | 76 percentage of participants |
| CHOP + Tositumomab | Progression-free Survival at 2 Years | 80 percentage of participants |
p-value: 0.1195% CI: [0.6, 1.05]Regression, Cox
Primary
Progression-free Survival at 5 Years
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date
Time frame: 0-5 years
Population: All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHOP + Rituximab | Progression-free Survival at 5 Years | 60 percentage of participants |
| CHOP + Tositumomab | Progression-free Survival at 5 Years | 66 percentage of participants |
Secondary
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal
Time frame: Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment
Population: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperuricemia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoalbuminemia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuro-other | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypokalemia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyponatremia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypophosphatemia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cardiovascular-other | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutropenia/granulocytopenia | 8 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ileus | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection w/o 3-4 neutropenia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with 3-4 neutropenia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Osteonecrosis | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Invol. movement/restlessness | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Joint,muscle,bone-other | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Depression | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness (not neuro) | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathic pain | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | PRBC transfusion | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain-other | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pancreatitis | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pruritus | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelet transfusion | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pleural effusions | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anxiety/agitation | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pleuritic pain | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis/infiltrates | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea without colostomy | 1 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rectal/perirectal pain | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Respiratory infect w/ neutrop | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | SGPT (ALT) increase | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Second primary | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Respiratory infection, unk ANC | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sinus tachycardia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Skin-other | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Double vision | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Syncope | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | SGOT (AST) increase | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombocytopenia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Seizures | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/embolism | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urinary frequency/urgency | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urinary tr infection, unk ANC | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vaginal bleeding | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Voice change/stridor/larynx | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sensory neuropathy | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 1 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight loss | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Abdominal pain/cramping | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Speech impairment | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Esophagitis/dysphagia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Stomatitis/pharyngitis | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Supraventricular arrhythmia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Tumor lysis syndrome | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 1 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weakness (motor neuropathy) | 1 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperglycemia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | ARDS | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ascites (non-malignant) | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anemia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Arrhythmia, NOS | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection, unk ANC | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Arthralgia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Arthritis | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cardiac ischemia/infarction | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cataract | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Insomnia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Catheter related infection | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cerebrovascular ischemia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Chest pain,not cardio or pleur | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | LVEF decrease/CHF | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constipation/bowel obstruction | 1 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cough | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ataxia (incoordination) | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 2 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukopenia | 4 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Delusions | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness/light headedness | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 4 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspepsia/heartburn | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Menses changes | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Edema | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue/malaise/lethargy | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Bone pain | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever without neutropenia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Myalgia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever, NOS | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Flu-like symptoms-other | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Gastric ulcer | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Myalgia/arthralgia, NOS | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Gynecomastia | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Headache | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hematologic-other | 0 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 1 Participants |
| CHOP + Rituximab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypertension | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sensory neuropathy | 10 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cardiac ischemia/infarction | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anxiety/agitation | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoalbuminemia | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Speech impairment | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypokalemia | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuro-other | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 5 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyponatremia | 4 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction | 9 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever, NOS | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypophosphatemia | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathic pain | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Stomatitis/pharyngitis | 4 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Esophagitis/dysphagia | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Myalgia | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Supraventricular arrhythmia | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Abdominal pain/cramping | 4 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ileus | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Delusions | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection w/o 3-4 neutropenia | 4 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutropenia/granulocytopenia | 127 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Tumor lysis syndrome | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with 3-4 neutropenia | 14 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cardiovascular-other | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukopenia | 104 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 42 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Invol. movement/restlessness | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Osteonecrosis | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anemia | 7 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Joint,muscle,bone-other | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ataxia (incoordination) | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weakness (motor neuropathy) | 4 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness (not neuro) | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypertension | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness/light headedness | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | PRBC transfusion | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis/infiltrates | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | ARDS | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain-other | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Depression | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Flu-like symptoms-other | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pancreatitis | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 64 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Bone pain | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelet transfusion | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pruritus | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Arrhythmia, NOS | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pleural effusions | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspepsia/heartburn | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hematologic-other | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pleuritic pain | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Arthralgia | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection, unk ANC | 4 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Gastric ulcer | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Arthritis | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rectal/perirectal pain | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | SGOT (AST) increase | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea | 4 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ascites (non-malignant) | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | SGPT (ALT) increase | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Respiratory infect w/ neutrop | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperglycemia | 10 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Second primary | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea without colostomy | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cataract | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 6 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sinus tachycardia | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Respiratory infection, unk ANC | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Edema | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Skin-other | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Catheter related infection | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Insomnia | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Syncope | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Gynecomastia | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cerebrovascular ischemia | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombocytopenia | 6 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue/malaise/lethargy | 11 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Menses changes | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/embolism | 6 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Chest pain,not cardio or pleur | 4 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urinary frequency/urgency | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Myalgia/arthralgia, NOS | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urinary tr infection, unk ANC | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Seizures | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperuricemia | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vaginal bleeding | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Double vision | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constipation/bowel obstruction | 5 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Voice change/stridor/larynx | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | LVEF decrease/CHF | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever without neutropenia | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 4 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cough | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight loss | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Headache | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight loss | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Abdominal pain/cramping | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anemia | 8 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anxiety/agitation | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Arthritis | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ascites (non-malignant) | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ataxia (incoordination) | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Bone pain | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cardiac ischemia/infarction | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Depression | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Edema | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Esophagitis/dysphagia | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hematologic-other | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ileus | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection, unk ANC | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Joint,muscle,bone-other | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | LVEF decrease/CHF | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukopenia | 102 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 68 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness (not neuro) | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Myalgia | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Myalgia/arthralgia, NOS | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 10 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuro-other | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathic pain | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutropenia/granulocytopenia | 136 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Osteonecrosis | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis/infiltrates | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pruritus | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rectal/perirectal pain | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Respiratory infect w/ neutrop | 5 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Respiratory infection, unk ANC | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Seizures | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Skin-other | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Speech impairment | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Stomatitis/pharyngitis | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/embolism | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Tumor lysis syndrome | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urinary frequency/urgency | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 10 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weakness (motor neuropathy) | 4 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | ARDS | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Arrhythmia, NOS | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Arthralgia | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cardiovascular-other | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cataract | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Catheter related infection | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cerebrovascular ischemia | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Chest pain,not cardio or pleur | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constipation/bowel obstruction | 4 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cough | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Delusions | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea without colostomy | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness/light headedness | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Double vision | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspepsia/heartburn | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea | 4 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue/malaise/lethargy | 9 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 26 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever without neutropenia | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever, NOS | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Flu-like symptoms-other | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Gastric ulcer | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Gynecomastia | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Headache | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperglycemia | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypertension | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperuricemia | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoalbuminemia | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypokalemia | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyponatremia | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypophosphatemia | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection w/o 3-4 neutropenia | 5 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with 3-4 neutropenia | 9 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Insomnia | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Invol. movement/restlessness | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Menses changes | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | PRBC transfusion | 5 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain-other | 3 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pancreatitis | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelet transfusion | 7 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pleural effusions | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pleuritic pain | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 2 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | SGOT (AST) increase | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | SGPT (ALT) increase | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Second primary | 6 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sensory neuropathy | 11 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sinus tachycardia | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Supraventricular arrhythmia | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Syncope | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombocytopenia | 47 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urinary tr infection, unk ANC | 0 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vaginal bleeding | 1 Participants |
| CHOP + Tositumomab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Voice change/stridor/larynx | 1 Participants |
Secondary
Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. 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. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. 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.
Time frame: Assessed 200 days and 365 days after initiation of therapy and then every 6 months until death
Population: All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHOP + Rituximab | Objective Response (Confirmed and Unconfirmed Complete and Partial Responses) | 224 participants |
| CHOP + Tositumomab | Objective Response (Confirmed and Unconfirmed Complete and Partial Responses) | 223 participants |