Status:
COMPLETED
Rituximab in Treating Patients With Follicular Non-Hodgkin's Lymphoma
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 o...
Detailed Description
OBJECTIVES: Primary * Compare the efficacy of induction therapy with rituximab followed by short- vs long-term maintenance therapy with rituximab, in terms of event-free survival, in patients with f...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed follicular lymphoma
- Grade 1, 2, 3a, or 3b disease by WHO staging system
- 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 12 weeks since prior systemic treatment
- 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
- 18 and over
- Performance status
- WHO 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Cardiovascular
- Ejection fraction ≥ 50% by echocardiography or MUGA
- Immunologic
- No acute or ongoing infection
- No HIV infection
- No active autoimmune disease
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 months after completion of the study treatment
- No uncontrolled diabetes mellitus
- No other medical condition that would preclude study participation
- No other malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
- No other condition (e.g., geographic proximity) that would preclude study compliance and follow-up
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Radiotherapy
- Prior rituximab allowed
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- More than 4 weeks since prior regular administration of corticosteroids
- Dose equivalent to ≤ 20 mg/day prednisone allowed for conditions other than lymphoma or lymphoma-related symptoms
- 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
- At least 12 months since prior anti-CD20 therapy
- Surgery
- Not specified
- Other
- More than 30 days since prior systemic tumor therapy
- More than 30 days since prior participation in another clinical trial
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
June 8 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2017
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00227695
Start Date
June 8 2004
End Date
December 19 2017
Last Update
May 15 2019
Active Locations (26)
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1
Clinical Center - Institute of Hematology
São Paulo, Brazil
2
Istituto Europeo di Oncologia IEO
Milan, Italy, 20141
3
Clinical Center Skopje
Skopje, North Macedonia, 1000
4
Clinical Center of Serbia
Belgrade, Serbia, SCG-11000