Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine

German CLL Study Group

Status and phase

Completed

Phase 2

Conditions

Leukemia

Treatments

Biological: alemtuzumab

Study type

Interventional

Funder types

Other

Identifiers

NCT00274976

GCLLSG-CLL2H

EU-20550

CDR0000455059

AMGEN-GCLLSG-CLL2H

MEDAC-GCLLSG-CLL2H

Details and patient eligibility

About

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.

PURPOSE: This phase II trial is studying how well giving alemtuzumab by injection works in treating patients with advanced chronic lymphocytic leukemia that did not respond to previous fludarabine.

Full description

OBJECTIVES:

Compare the safety and efficacy of subcutaneous alemtuzumab vs intravenous alemtuzumab in patients with fludarabine-refractory advanced chronic lymphocytic leukemia.
Determine the response in patients with high-risk genetic abnormalities (unmutated immunoglobulin variable heavy-chain [IgVH] status, del [17p], del [11q]) treated with subcutaneous alemtuzumab after progression on fludarabine.

OUTLINE: This is a multicenter study.

Patients receive alemtuzumab IV once, followed 1 week later by alemtuzumab subcutaneously once weekly for up to 12 weeks.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS: