Allogeneic Stem Cell Transplantation in Chronic Lymphocytic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
University Hospital Carl Gustav Carus
Deutsche Klinik fuer Diagnostik
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: June 15, 2006
Last updated: January 28, 2009
Last verified: January 2009

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)

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 400 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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.

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
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Please refer to this study by its identifier: NCT00337519

Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09113
Uniklinikum Carl Gustav Carus
Dresden, Germany, 01307
Deutsche Klinik für Diagnostik GmbH
Wiesbaden, Germany, 65191
Sponsors and Collaborators
Charite University, Berlin, Germany
University Hospital Carl Gustav Carus
Deutsche Klinik fuer Diagnostik
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 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
allogeneic stem cell transplantation

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on February 04, 2016