A Randomized, Phase III Trial to Determine the Effect of Consolidation With Rituximab (IDEC C2B8-Mabthera) in Patients With CD20+ Follicular or Mantle Cell Lymphoma Having Received Induction Therapy With Rituximab Weekly x 4
18 Years
N/A
Both
Lymphoma
Trial Information
A Randomized, Phase III Trial to Determine the Effect of Consolidation With Rituximab (IDEC C2B8-Mabthera) in Patients With CD20+ Follicular or Mantle Cell Lymphoma Having Received Induction Therapy With Rituximab Weekly x 4
OBJECTIVES:
- Assess the clinical efficacy of consolidation treatment with rituximab in terms of
response rate in patients with follicular (closed to accrual 9/18/00) or mantle cell
lymphoma.
- Compare the event free survival of patients after induction with or without
consolidation.
- Compare the tolerability of these two treatment regimens by these patients.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to participating center, histology (follicular (closed to accrual 9/18/00) vs
mantle cell), status of disease (de novo vs relapsed vs resistant), response after induction
(stable disease vs partial or complete response), and treatment status (treated vs
untreated).
All patients receive induction therapy consisting of rituximab IV over 3-5 hours once a week
during weeks 1-4. Patients are then randomized to one of two treatment arms.
- Arm I: Patients are observed.
- Arm II: Patients receive rituximab IV over 3-5 hours once a week during weeks 12, 20,
28, and 36.
Patients are followed weekly for the first month; every 8 weeks for the next 8 months; then
at 12, 18, and 24 months; and then annually for the next 3 years.
PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study
within 3-4 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven CD20 positive follicular (closed to accrual 9/18/00) or mantle
cell lymphoma
- Untreated "de novo" disease OR
- Chemotherapy resistant disease OR
- Relapsing disease
- Bidimensionally measurable disease
- No symptomatic CNS disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- No hepatitis B or C
Renal:
- Creatinine no greater than 2 times ULN
Cardiovascular:
- Ejection fraction at least 50%
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active opportunistic infections
- HIV negative
- No prior malignancy within 5 years except adequately treated carcinoma in situ of the
cervix or localized nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior antibody based therapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (at least 6 weeks since nitrosoureas) and
recovered
- No concurrent chemotherapy
Endocrine therapy:
- At least 4 weeks since prior corticosteroids, unless chronic dose no greater than 20
mg/day for nonlymphoma related condition
- No other concurrent corticosteroids
Radiotherapy:
- Not specified
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Michele Ghielmini, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 35/98
NCT ID:
NCT00003280
Start Date:
January 1998
Completion Date:
March 2002
Related Keywords:
- Lymphoma
- stage I mantle cell lymphoma
- contiguous stage II mantle cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- Lymphoma
- Lymphoma, Mantle-Cell
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