NCT00206726

Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)

Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy. Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission (CR) will receive no further treatment but will be followed for response.

Detailed description

As of April, 2011 Bayer transferred this record to Genzyme. Genzyme is now the sponsor of this trial. NOTE: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Conditions

• Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Type	Name	Description
DRUG	Alemtuzumab plus Fludarabine	Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2005-09-21
• Last updated: 2016-08-29
• Results posted: 2011-01-13

Locations

27 sites across 1 country: United States