Status:
COMPLETED
Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 rit...
Detailed Description
OBJECTIVES: Primary * To compare time to rituximab failure between the rituximab scheduled and rituximab retreatment arms. Secondary * To compare the time to first cytotoxic therapy between the ri...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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\*
- Hemoglobin at least 10 g/dL\*
- Platelet count at least 100,000/mm\^3\*
- NOTE: \*Without growth factor and/or transfusion support
- Hepatic
- Bilirubin no greater than 2 times upper limit of normal (ULN) OR direct bilirubin normal for patients with Gilbert's Syndrome
- The aspartate transaminase (AST) and alanine transaminase (ALT) ratio (AST/ALT) no greater than 5 times ULN
- Hepatitis B surface antigen negative
- Renal
- Creatinine no greater than 2 times ULN
- EXCLUSION CRITERIA:
- 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
Exclusion
Key Trial Info
Start Date :
January 23 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
545 Patients enrolled
Trial Details
Trial ID
NCT00075946
Start Date
January 23 2004
End Date
August 1 2021
Last Update
February 1 2024
Active Locations (483)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72903
3
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505