Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring refractory chronic lymphocytic leukemia, T-cell large granular lymphocyte leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed T-cell large granular lymphocytic (T-LGL) leukemia associated with clinically significant hematocytopenia demonstrated by one of the following values while off growth factor support: Absolute neutrophil count less than 1,000/mm^3 Hemoglobin less than 8 g/dL Platelet count less than 50,000/mm^3 Clinically evaluable disease with peripheral blood T-LGL leukemia cells expressing the CD3+, CD8+ phenotype detectable by FACS Monoclonal T-cell population in peripheral blood (circulating mononuclear cells) demonstrated by TCR beta or gamma chain gene rearrangement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: More than 2 months Hematopoietic: See Disease Characteristics No active major bleeding episode within the past 4 weeks Hepatic: Direct bilirubin less than 1.5 mg/dL Renal: Creatinine less than 2.0 mg/dL Other: No concurrent serious active infection Patients with fever without apparent site of infection may begin study while on antibiotics as long as the following are true: No pathogenic organism in culture Afebrile (maximum temperature less than 38°C) for at least 5 days HIV negative No other primary cancer other than basal cell skin cancer Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interferon Concurrent filgrastim (G-CSF), sargramostim (GM-CSF), interleukin-11, or similar sustained-release/long-acting product (e.g., pegylated G-CSF) allowed if dose established at least 4 weeks prior to study participation No concurrent interferon Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: Concurrent corticosteroids allowed if dose established at least 3 weeks prior to study participation Radiotherapy: Not specified Surgery: Not specified Other: At least 1 week since completion of prior antibiotic regimen for serious infectious episode No other concurrent investigational drugs
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support