NCT00274976

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

Subcutaneous Campath-1H in Fludarabine-Refractory CLL

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: German CLL Study Group · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	alemtuzumab

Timeline

• Start date: 2002-09-01
• Completion: 2009-08-01
• First posted: 2006-01-11
• Last updated: 2013-11-06

Locations

35 sites across 2 countries: Austria, Germany