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

Phase 2

Completed

• Conditions: Leukemia

• Registration Number: NCT00274976
• Lead Sponsor: German CLL Study Group

Brief 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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2006-01-10
• Study First Submitted QC: 2006-01-10
• Study First Posted: 2006-01-11
• Status Verified: 2006-05
• Study Completion: 2009-08
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response
Safety and efficacy

Trial Locations

Locations (35)

Allgemeines Krankenhaus der Stadt Wien; 🇦🇹 Vienna, Austria

Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie; 🇩🇪 Ansbach, Germany

Specialist Practice for Oncology; 🇩🇪 Aschaffenburg, Germany

Humaine - Clinic; 🇩🇪 Bad Saarow, Germany

Haematolo-Onkologische Schwerpunktpraxis - Berlin; 🇩🇪 Berlin, Germany

Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch; 🇩🇪 Berlin, Germany

Hospital Kuchwald Chemnitz; 🇩🇪 Chemnitz, Germany

Universitaetsklinikum Essen; 🇩🇪 Essen, Germany

Staedtische Kliniken Esslingen; 🇩🇪 Esslingen, Germany

Krankenhaus Nordwest; 🇩🇪 Frankfurt, Germany

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