Rituximab in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Biological: rituximab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003849

CDR0000067010 (Registry Identifier)

NCI-2012-02298 (Registry Identifier)

NCCTG-987851

Details and patient eligibility

About

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them.

PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have non-Hodgkin's lymphoma or Hodgkin's disease.

Full description

OBJECTIVES: I. Determine the response rate (complete or partial) to rituximab in previously untreated patients with stage III or IV CD20+ B-cell follicular small cleaved cell non-Hodgkin's lymphoma. II. Determine the response rate (complete or partial) to rituximab in patients with relapsed CD20+ Hodgkin's disease. III. Determine the time to progression and time to chemotherapy in these patients after treatment with rituximab.

OUTLINE: Patients are stratified according to disease (follicular small cleaved cell non-Hodgkin's lymphoma vs relapsed Hodgkin's disease). Patients receive rituximab IV over 4-6 hours on day 1 weekly for 4 weeks. Patients are followed at 1, 3, 6, 9, and 12 months, then every 6 months for 3 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 21-32 patients will be accrued for each arm of this study within 7-10.5 months.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS: Histologically proven stage IIIA or stage IVA B-cell follicular small cleaved cell non-Hodgkin's lymphoma Tumor cells express CD20 No prior chemotherapy or radiotherapy Stable disease that would otherwise be observed OR Histologically proven relapsed Hodgkin's disease of any stage Tumor cells express CD20 Bidimensionally measurable disease Masses (e.g., enlarged lymph nodes) must be at least 1.5 cm X 1.5 cm by CT, MRI, or x-ray Splenic enlargement considered measurable if spleen palpable at least 3 cm below the left costal margin No CNS lymphoma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: No more than 5,000 circulating tumor cells Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception during and for at least 12 months following study HIV negative No other active malignancies

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

rituximab

Experimental group

Description:

Patients receive rituximab IV over 4-6 hours on day 1 weekly for 4 weeks. Patients are followed at 1, 3, 6, 9, and 12 months, then every 6 months for 3 years, then annually thereafter.

Treatment:

Biological: rituximab