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
- Compare the response rate and quality of remission in patients with relapsed follicular
non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and
prednisone (CHOP) with or without rituximab.
- Compare the event-free survival and overall survival of patients treated with these
- Determine the effect of rituximab as maintenance therapy on progression-free survival
of these patients.
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).
- Arm I (closed as of 12/20/04): Patients receive induction chemotherapy comprising
cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral
prednisone on days 1-5 (CHOP chemotherapy). Treatment repeats every 3 weeks for 6
courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive CHOP chemotherapy as in arm I. Rituximab IV is
administered 1 hour after prednisone and before the IV drugs.
- 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.
- Arm I: Patients receive no further therapy.
- Arm II: Beginning 8 weeks after the last CHOP course, patients receive rituximab
IV once every 3 months for up to 2 years in the absence of disease progression or
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.
Allocation: Randomized, Primary Purpose: Treatment
Response as assessed by modified Lexcor criteria after induction therapy
M. H. J. Van Oers, MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
United States: Federal Government