Combination Chemotherapy With or Without Rituximab in Non-Hodgkin's Lymphoma (IDEC-C2B8)
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage I adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma according to REAL classification Diagnosed within the past 6 weeks CD20+ disease Ann Arbor stage II, III, or IV disease or stage I bulky disease International Prognostic Index (IPI) score of 0 or 1 Score 0 defined by all of the following: Stage I or II disease ECOG performance status of 0 or 1 Lactic dehydrogenase (LDH) no greater than upper limit of normal (ULN) Score 1 defined by 1 of the following: Stage I or II disease; ECOG performance status of 0 or 1; and LDH greater than ULN Stage I or II disease; ECOG performance status 2 or 3; and LDH no greater than ULN Stage III or IV disease; ECOG performance status 0 or 1; and LDH no greater than ULN Previously untreated disease Mediastinal B-cell lymphoma allowed No secondary lymphoma after prior chemotherapy or radiotherapy for other malignancies No transformed lymphoma No primary CNS lymphoma No primary gastrointestinal (MALT) lymphoma No post-transplant lymphoproliferative disorder PATIENT CHARACTERISTICS: Age 18 to 60 Performance status See Disease Characteristics ECOG 0-3 Life expectancy At least 3 months Hematopoietic Not specified Hepatic Bilirubin no greater than 2.0 mg/dL* Transaminases no greater than 3 times normal* No active chronic hepatitis B or C infection NOTE: *Unless related to lymphoma Renal Creatinine no greater than 2 times normal* NOTE: *Unless related to lymphoma Cardiovascular No myocardial infarction within the past 6 months No uncompensated heart failure No dilatative cardiomyopathy No coronary heart disease with ST segment depression on ECG No severe uncompensated hypertension Pulmonary No chronic lung disease with hypoxemia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No known allergic reactions against foreign proteins No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix No concurrent disease that would preclude study treatment No active infections requiring systemic antibiotics or antiviral medications No severe uncompensated diabetes mellitus No clinical signs of cerebral dysfunction No severe psychiatric disease PRIOR CONCURRENT THERAPY: Biologic therapy No prior murine antibodies Chemotherapy No other concurrent anticancer chemotherapy Endocrine therapy Not specified Radiotherapy No concurrent response-adapted (slow response or unconfirmed complete response) radiotherapy Surgery Not specified Other No prior lymphoma-specific treatment More than 12 weeks since prior participation in another clinical trial No prior participation in this study No other concurrent study medication
Sites / Locations
- Tom Baker Cancer Centre
- Cross Cancer Institute
- CancerCare Manitoba
- The Moncton Hospital
- Dr. H. Bliss Murphy Cancer Centre
- QEII Health Sciences Center
- Cancer Centre of Southeastern Ontario at Kingston
- Grand River Regional Cancer Centre
- London Regional Cancer Program
- Ottawa Health Research Institute - General Division
- Niagara Health System
- Odette Cancer Centre
- Univ. Health Network-The Toronto General Hospital
- Univ. Health Network-Princess Margaret Hospital
- Trillium Health Centre - West Toronto
- PEI Cancer Treatment Centre,Queen Elizabeth Hospital
- Hopital Charles LeMoyne
- Hopital Maisonneuve-Rosemont
- CHUM - Hopital Notre-Dame
- McGill University - Dept. Oncology
- Hopital du Sacre-Coeur de Montreal
- CHA-Hopital Du St-Sacrement
- Centre hospitalier universitaire de Sherbrooke
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Arm A: CHOP-21
Arm B: CHOP-21 + Rituximab
Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle: day 22 Total number of cycles 6
Rituximab 375 mg/m² i.v. day 1* Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6