Allogeneic Stem Cell Transplantation in Chronic Lymphocytic Leukemia
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Procedure: allogeneic stem cell transplantation Drug: Alemtuzumab |
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 |
| Official Title: | Chemo-Immunotherapy With Allogeneic Blood Stem Cell Transplantation in Patients With Chronic Lymphocytic Leukemia (Study #02) |
- Progression-free survival [ Time Frame: 400 days ] [ Designated as safety issue: Yes ]
- safety according to common toxicity criteria (CTC) [ Time Frame: at discharge and until last follow up ] [ Designated as safety issue: No ]
- rate of primary and secondary graft failure [ Time Frame: until last follow up ] [ Designated as safety issue: No ]
- rate of acute and chronic GVHD [ Time Frame: day 100 and last follow up ] [ Designated as safety issue: No ]
- response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- chimerism [ Time Frame: day 100 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 82 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
see detailed description
|
Procedure: allogeneic stem cell transplantation
see detailed description
Drug: Alemtuzumab
alemtuzumab is given as cytoreductive pre-treatment with the last application of alemtuzumab scheduled for day 14
|
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.
Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Germany | |
| Klinikum Chemnitz gGmbH | |
| Chemnitz, Germany, 09113 | |
| Uniklinikum Carl Gustav Carus | |
| Dresden, Germany, 01307 | |
| Deutsche Klinik für Diagnostik GmbH | |
| Wiesbaden, Germany, 65191 | |
| Study Chair: | Johannes Schetelig, MD | University Hospital Carl Gustav Carus, Dresden |
More Information
No publications provided
| Responsible Party: | Dr. J. Schetelig, University Hospital Carl Gustav Carus |
| ClinicalTrials.gov Identifier: | NCT00337519 History of Changes |
| Other Study ID Numbers: | CLL #02, DJCLS-R03/01 |
| Study First Received: | June 15, 2006 |
| Last Updated: | January 28, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Charite University, Berlin, Germany:
|
chronic lymphocytic leukemia reduced intensity conditioning alemtuzumab allogeneic stem cell transplantation |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Alemtuzumab Campath 1G Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013