Status and phase
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Study type
Funder types
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About
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving rituximab over a short period of time is more effective than giving it over a long period of time in treating follicular non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying rituximab to see how well it works when given over a short period of time compared to when given over a long period of time in treating patients with follicular non-Hodgkin's lymphoma.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study.
NOTE: *Patients treated with radiotherapy only are considered as therapy-naïve.
NOTE: **Defined as a mass or lymph node conglomerate ≥ 5 cm diameter.
Maintenance therapy: Patients start maintenance therapy within 7 days of randomization.
After completion of study treatment, patients are followed every 3 months until disease progression or relapse and then annually for up to 10 years after randomization.
PROJECTED ACCRUAL: A total of 270 patients will be accrued for this study within 3 years.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed follicular lymphoma
CD20-positive by immunohistochemistry
Previously untreated disease OR meets 1 of the following criteria for response to prior treatment:
Chemotherapy-resistant disease
Relapsed or progressive disease
Stable disease
At least 1 bidimensionally measurable lesion ≥ 11 mm by CT scan or MRI
No transformation to high-grade lymphoma secondary to low-grade follicular lymphoma
No prior or current CNS disease (i.e., CNS lymphoma or lymphomatous meningosis) 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
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
More than 4 weeks since prior regular administration of corticosteroids
No concurrent corticosteroids for prevention or treatment of side effects except acute life-threatening side effects
Radiotherapy
Prior radiolabeled anti-CD20 therapy (administered alone or in combination with cytostatic drugs) allowed provided patient has achieved partial or complete response after the therapy
Surgery
Other
Primary purpose
Allocation
Interventional model
Masking
270 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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