Leukemia Clinical Trial
Official title:
PHASE I STUDY OF T-CELL LARGE GRANULAR LYMPHOCYTIC LEUKEMIA USING THE MIK-BETA 1 MONOCLONAL ANTIBODY DIRECTED TOWARD THE IL-2R BETA SUBUNIT
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.
OBJECTIVES:
- Evaluate the toxicity of murine monoclonal antibody Mik-beta-1 (MOAB Mik-beta-1) in
patients with T-cell large granular lymphocytic leukemia associated with
granulocytopenia, anemia, or thrombocytopenia.
- Determine the clinical response in patients treated with this drug.
- Assess the effect of this drug on the number of circulating CD3+, CD8+ expressing
granular lymphocytes and the number of polymorphonuclear leukocytes, red blood cells,
and platelets in this patient population.
- Monitor patients for the time course of decline in circulating infused MOAB Mik-beta-1
and for the production of human antibodies to IV infused murine MOAB Mik-beta-1.
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody Mik-beta-1 (MOAB Mik-beta-1) IV over 2 hours on days 1,
4, 7, and 10. Patients achieving a complete response (CR) or partial response (PR) may
receive 1 additional course beginning no sooner than 4 weeks after completion of the first
course, in the absence of antibodies to MOAB Mik-beta-1. Treatment continues in the absence
of disease progression, unacceptable toxicity, or severe allergic reaction.
Cohorts of 3-6 patients receive escalating doses of MOAB Mik-beta-1 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose-limiting toxicity.
Patients are followed at 6-10 days and at 4-6 weeks after therapy. Patients with a PR or CR
may be followed every 6 months for 2 years or until relapse. All patients are followed for
survival.
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.
;
Primary Purpose: Treatment
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