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Allogeneic Stem Cell Transplantation in Chronic Lymphocytic Leukemia

Disease Information

Descriptive Information
Brief Title † Allogeneic Stem Cell Transplantation in Chronic Lymphocytic Leukemia
Official Title † Chemo-Immunotherapy With Allogeneic Blood Stem Cell Transplantation in Patients With Chronic Lymphocytic Leukemia (Study #02)
Brief 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.
Detailed Description Patients with relapsed or refractory CLL who are eligible for the study receive a cytoreductive therapy until SCT. Irrespective to the formal response, patients proceed to allogeneic SCT after fludarabine-based reduced-intensity conditioning. The use of granulocyte colony-stimulating factor (G-CSF)-mobilized peripheral blood stem cells > 3 x 10E6 CD34 cells/kg is recommended, but bone marrow > 1 x 10E8 MNC/kg is accepted. GVHD-prophylaxis is based on cyclosporine A adapted to blood levels (150 to 200 ng/mL) over a period of three months. In Phase I of the study, alemtuzumab has been applied as part of the conditioning regimen until day 5. In Phase II, alemtuzumab is given as cytoreductive pre-treatment with the last application of alemtuzumab scheduled for day 14 and after Amendment II in September 2006 scheduled for day 28. Furthermore methotrexate is given on days 1, 3, 6. and 11 at a projected cumulative dose of 45 mg/m2. Subsequent immunosuppressive therapy depends on the occurrence of GvHD, the development of chimerism, and residual disease. Patients with relapsing or residual disease (minimal residual disease excluded) who do not suffer from GvHD should receive donor lymphocytes in increasing dosages. The initial dose is 1 x 105/kg T-cells in unrelated donors and 1 x 106/kg in matched related donors. If no GvHD develops within 6-8 weeks, the next higher dosage is applied.
Study Phase Phase 2
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Progression-free survival
Secondary Outcome Measure † safety according to common toxicity criteria (CTC)
Condition † Chronic Lymphocytic Leukemia
Intervention † Procedureallogeneic stem cell transplantation
Study Arms / Comparison Groups 1 see detailed description
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 82
Start Date † January 2003
Completion Date April 2009
Primary Completion Date April 2009
Eligibility Criteria † Inclusion Criteria: - written informed consent - sufficient organ function - availability of an HLA-compatible donor (related or unrelated) - age = 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
Gender Both
Ages N/A - 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Germany
Administrative Information
NCT ID † NCT00337519
Organization ID CLL #02
Secondary IDs †† DJCLS-R03/01
Responsible Party
Study Sponsor † Charite University, Berlin, Germany
Collaborators †† University Hospital Carl Gustav Carus
Investigators † Study Chair: Johannes Schetelig, MD, University Hospital Carl Gustav Carus, Dresden
Information Provided By
Verification Date January 2009
First Received Date † June 15, 2006
Last Updated Date January 28, 2009
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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