Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Completed · Phase 3

Conditions studied: Lymphoma

In brief

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which rituximab regimen is more effective in treating indolent non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and comparing them to see how well they work in treating patients with low tumor burden indolent stage III non-Hodgkin's lymphoma or stage IV non-Hodgkin's lymphoma.

Key facts

Study ID

NCT00075946

Run by

Eastern Cooperative Oncology Group

People needed

545

Starts

2004-01-23

Expected to finish

2021-08-01

Last updated by the study team

2024-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed non-Hodgkin's lymphoma, including 1 of the following:
• Follicular grade 1 or 2
• Small lymphocytic
• Marginal zone (nodal)
• Marginal zone (splenic)
• Mucosa-associated lymphoid tissue (MALT)
• Stage III or IV disease
• Must meet the following criteria for low tumor burden:
• No nodal or extranodal mass at least 7 cm
• Less than 3 nodal masses greater than 3 cm in diameter
• No systemic symptoms or B symptoms
• No splenomegaly greater than 16 cm by a computed tomography (CT) scan
• No evidence of risk of compression of a vital organ (i.e., ureteral or epidural)
• No leukemic phase with greater than 5,000/mm\^3 circulating lymphocytes
• No cytopenias, defined as any of the following:
• Platelet count less than 100,000/mm\^3
• Hemoglobin less than 10 g/dL
• Absolute neutrophil count less than 1,500/mm\^3
• At least 1 objective measurable disease parameter
• Abnormal positron emission tomography (PET) scans will not constitute evaluable disease unless verified by CT scan or other appropriate imaging
• Age: 18 and over
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Must meet the following criteria for labs:
• Hematopoietic
• Absolute neutrophil count at least 1,500/mm\^3*

You may not qualify if…

• Evidence of transformation to a large cell histology
• Pregnant or nursing. Fertile patients must use effective contraception
• HIV positive
• Uncontrolled active infection
• Other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• Prior immunotherapy for lymphoma
• Prior chemotherapy for lymphoma
• Concurrent chemotherapy
• Prior radiotherapy for lymphoma
• Concurrent radiotherapy
• Concurrent radioimmunotherapy

Where it is running

• Hembree Mercy Cancer Center at St. Edward Mercy Medical Center — Fort Smith, Arkansas, United States
• Arkansas Cancer Research Center at University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Providence Saint Joseph Medical Center - Burbank — Burbank, California, United States
• North Bay Cancer Center — Fairfield, California, United States
• Kaiser Permanente - Fremont — Fremont, California, United States
• Kaiser Permanente Medical Center - Hayward — Hayward, California, United States
• Memorial Medical Center — Modesto, California, United States
• Kaiser Permanente Medical Center - Oakland — Oakland, California, United States
• Desert Regional Medical Center Comprehensive Cancer Center — Palm Springs, California, United States
• Veterans Affairs Medical Center - Palo Alto — Palo Alto, California, United States
• Kaiser Permanente Medical Center - Redwood City — Redwood City, California, United States
• Kaiser Permanente Medical Center - Richmond — Richmond, California, United States
• Kaiser Permanente Medical Center - Roseville — Roseville, California, United States
• South Sacramento Kaiser-Permanente Medical Center — Sacramento, California, United States
• Kaiser Permanente Medical Center - Sacramento — Sacramento, California, United States
• Kaiser Permanente Medical Office -Vandever Medical Office — San Diego, California, United States
• Kaiser Permanente Medical Center - San Francisco Geary Campus — San Francisco, California, United States
• Kaiser Permanente Medical Center - Santa Teresa — San Jose, California, United States
• Kaiser Foundation Hospital - San Rafael — San Rafael, California, United States
• Kaiser Permanente Medical Center - Santa Clara Kiely Campus — Santa Clara, California, United States
• Kaiser Permanente Medical Center - Santa Rosa — Santa Rosa, California, United States
• Kaiser Permanente Medical Center - South San Francisco — South San Francisco, California, United States
• Stanford Cancer Center — Stanford, California, United States
• Kaiser Permanente Medical Facility - Stockton — Stockton, California, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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