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

Not Applicable

Completed

• Conditions: Leukemia
• Interventions: Biological: alemtuzumab

• Registration Number: NCT00021151
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2000-01
• Primary Completion: 2001-04
• Study First Submitted: 2001-07-11
• Study Completion: 2002-05
• Study First Submitted QC: 2004-04-12
• Study First Posted: 2004-04-13
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-07
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alemtuzumab	alemtuzumab	-

Trial Locations

Locations (1)

Ireland Cancer Center; 🇺🇸 Cleveland, Ohio, United States