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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00021151
Recruitment Status : Completed
First Posted : April 13, 2004
Last Update Posted : January 9, 2014
National Cancer Institute (NCI)
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Leukemia Biological: alemtuzumab Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Primary Completion Date : April 2001
Actual Study Completion Date : May 2002

Arm Intervention/treatment
Experimental: Alemtuzumab Biological: alemtuzumab

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00021151

United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Genzyme, a Sanofi Company
Study Chair: Bernard J. Silver, MD University Hospitals Seidman Cancer Center

Publications of Results:
Responsible Party: Case Comprehensive Cancer Center Identifier: NCT00021151     History of Changes
Other Study ID Numbers: ILEX1999
First Posted: April 13, 2004    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014

Keywords provided by Case Comprehensive Cancer Center:
refractory chronic lymphocytic leukemia
prolymphocytic leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Prolymphocytic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents