Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study
Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study.
Induction: Patients are randomized to one of two treatment arms. Patients are stratified according to participating center, prior treatment with purine analogues, age, number of prior induction treatments and best response obtained (complete vs partial remission vs no change/progressive disease), time since diagnosis (less than 2 years vs more than 2 years), and bulky disease (less than 10 cm vs greater than 10 cm).
Maintenance: Patients who achieve partial or complete remission are then randomized to one of two treatment arms. Patients are stratified according to rituximab administration during induction (yes vs no), quality of the response (complete vs partial remission vs no change/progressive disease), and participating center.
Patients are followed every 3 months for 2 years and then every 4 months thereafter.
PROJECTED ACCRUAL: A total of 752 patients will be accrued for this study within 6 years.
DISEASE CHARACTERISTICS:
Histologically or cytologically proven stage III or IV follicular non-Hodgkin's lymphoma (NHL)
Complete or partial remission or no change for at least 4 weeks after completion of prior therapy OR progression during one of a maximum of 2 prior therapy regimens
CD20 positive
At least 1 bidimensionally measurable mass
No greater than 10,000,000/mL circulating tumor cells
IgG levels at least 3 g/L
No low-grade NHL transformed into intermediate- or high-grade NHL
No symptomatic CNS lymphoma
No bone marrow involvement only NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Kelowna, British Columbia V1Y 5L3, Canada
Surrey, British Columbia V3V 1Z2, Canada
St. John's, Newfoundland and Labrador A1B 3V6, Canada
Halifax, Nova Scotia B3H 1V7, Canada
Thunder Bay, Ontario P7A 7T1, Canada
Toronto, Ontario M4N 3M5, Canada
Amersfont, 3016 CP, Netherlands
La Zierikzee, NL-4300, Netherlands
Spykenisse, NL-3200 GA, Netherlands
Weert Be, 6001, Netherlands
Lisbon, 1099-023 Codex, Portugal
Brooklyn Square, 1577, South Africa
Aylesbury-Buckinghamshire, England HP21 8AL, United Kingdom
Cambridge, England CB2 2QQ, United Kingdom
Hampstead, London, England NW3 2QG, United Kingdom
Merseyside, England CH63 4JY, United Kingdom
Prescot Merseyside, England L35 5DR, United Kingdom
Royal Tunbridge Wells, Kent, England TN2 4QJ, United Kingdom
Swansea, England SA 2 8QA, United Kingdom
Taunton Somerset, England TA1 5DA, United Kingdom
Torquay Devon, England TQ2 7AA, United Kingdom
Newport Gwent, Wales NP9 2UB, United Kingdom