Allogeneic Stem Cell Transplantation in Chronic Lymphocytic Leukemia

• Status: Unknown status
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with advanced chronic lymphocytic leukemia (CLL) have a poor long-term prognosis. Allogeneic stem cell transplantation (SCT) in patients with CLL has only rarely been performed in the past because the clinical outcome after myeloablative conditioning was poor, mainly due to the high treatment-related mortality. However long-term disease-free survival after allogeneic SCT has been reported. Recently it has been demonstrated by our group and others that non-relapse mortality can be reduced significantly with the use of reduced-intensity conditioning regimens. Yet, graft versus host disease (GVHD) remains an important problem in this setting.

Alemtuzumab is an effective drug for the treatment of patients with advanced CLL and has been successfully applied for GVHD-prophylaxis in the setting of myeloablative and reduced-intensity conditioning regimens. The goal of the present study is to evaluate the role of alemtuzumab as part of a fludarabine-based reduced intensity conditioning regimen for allogeneic SCT in patients with advanced CLL.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborators: Deutsche Klinik fuer Diagnostik; University Hospital Carl Gustav Carus
• Treatments: Alemtuzumab

Criteria

Inclusion Criteria:

• written informed consent

• sufficient organ function

• availability of an HLA-compatible donor (related or unrelated)

• age < 65 years

• karnofsky index > = 70%

• B-CLL requiring treatment after failure of at least one prior cytostatic treatment

Exclusion Criteria:

• positive HIV-serology

• pregnancy

• intolerance to study drugs

• second neoplasia

• serious infections