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