Status:
TERMINATED
Rituximab and GM-CSF in Treating Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
15+ years
Phase:
PHASE2
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: * Determine the complete and overall response rate in patients with B-cell chronic lymphocytic leukemia treated with rituximab and sargramostim (GM-CSF). * Determine the time to progressi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of B-cell chronic lymphocytic leukemia meeting 1 of the following criteria:
- Previously treated stage III or IV or earlier stage disease with evidence of active disease, as defined by ≥ 1 of the following:
- Weight loss \> 10% within the past 6 months
- Extreme fatigue
- Fever or night sweats without evidence of infection
- Worsening anemia or thrombocytopenia
- Progressive lymphocytosis with a rapid lymphocyte doubling time
- Marked hypogammaglobulinemia or paraproteinemia
- Lymphadenopathy \> 5 cm in diameter
- Previously untreated stage 0-II disease with symptoms or significant fatigue or at high risk of progression due to of B2 microglobulin \> 3.0 mg/mL
- Patients who are ≥ 70 years of age with previously untreated stage III or IV or earlier stage disease requiring treatment but who refused chemotherapy are eligible
- PATIENT CHARACTERISTICS:
- Performance status
- Zubrod 0-2
- Life expectancy
- Not specified
- Hematopoietic
- See Disease Characteristics
- Hepatic
- Bilirubin \< 2.0 mg/dL\* (elevated bilirubin allowed if due to of Gilbert's disease) NOTE: \*Liver dysfunction due to lymphocytic organ infiltration allowed
- Renal
- Creatinine \< 2.5 mg/dL\* NOTE: \*Renal dysfunction due to lymphocytic organ infiltration allowed
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active viral infection (e.g., viral hepatitis)
- PRIOR CONCURRENT THERAPY:
- Chemotherapy
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00265915
Start Date
July 1 2005
End Date
March 1 2006
Last Update
August 12 2014
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