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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CAMPATH-1H Compassionate Treatment In Patients With PLL Who Have Failed At Least One Prior Regimen And CLL Patients Who Have Failed Fludarabine Therapy|
|Study Start Date:||January 2000|
|Study Completion Date:||May 2002|
|Primary Completion Date:||April 2001 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00021151
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Bernard J. Silver, MD||University Hospitals Seidman Cancer Center|