Compassionate Use of Campath-1H in Treating Patients With Refractory Prolymphocytic Leukemia or Chronic Lymphocytic Leukemia

Case Comprehensive Cancer Center2 enrolled

Overview

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Compassionate use refers to providing a drug to a patient on humanitarian grounds before the drug has received official approval. PURPOSE: Compassionate use of Campath-1H in treating patients who have refractory prolymphocytic leukemia or chronic lymphocytic leukemia.

OBJECTIVES: I. Expand access to Campath-1H for patients with refractory prolymphocytic leukemia or chronic lymphocytic leukemia. OUTLINE: Patients receive Campath-1H IV over 2 hours on days 1, 3, and 5. Treatment repeats weekly for 4-12 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: Not specified

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia

Interventions

alemtuzumabBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: Confirmed prolymphocytic leukemia (PLL) or chronic lymphocytic leukemia (CLL) PLL that has failed at least 1 prior regimen CLL that has failed prior fludarabine, defined as: No response Disease progression while receiving therapy OR Relapse within 6 months of completion of last dose PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) (unless secondary to direct liver infiltration with CLL) Renal: Creatinine no greater than 2 times ULN Other: HIV negative No active infection No other severe concurrent disease No mental disorders No prior allergic reaction to rat or mouse-derived CDR-grafted humanized monoclonal antibodies Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified

Locations (1)

Ireland Cancer Center

Cleveland, Ohio, United States

Data from ClinicalTrials.gov

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