Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia (NCT00019032) | Clinical Trial Compass
CompletedPhase 1
Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia
United States25 participantsStarted 1996-03
Plain-language summary
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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), sa…