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Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI /Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide

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ClinicalTrials.gov Identifier: NCT00125606
Recruitment Status : Terminated (insufficient patient recruitement)
First Posted : August 1, 2005
Last Update Posted : December 18, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
For patients with acute myeloid leukemia (AML), allogeneic hematopoetic stem cell transplantation (HSCT) is one of the most potent treatment options currently available. In order to overcome the high risk of fatal treatment-related complications, reduced intensity and nonmyeloablative conditioning regimens for allogeneic HSCT are currently being explored in various hematological malignancies including AML. At least for allogeneic HSCT in AML, the optimal dose-intensity of preparative regimens for disease control at an acceptable rate of treatment-related lethal complications has not been determined. The investigators, therefore, evaluated reduced intensity myeloablative conditioning with 8 Gy TBI and fludarabine in AML patients considered ineligible for conventional conditioning in a phase 2 trial (data published in BLOOD by Stelljes et al., 2005). The results suggest that with 8 Gy TBI/fludarabine, conditioning related and unrelated donor transplants can be performed in AML patients in first or second complete remission (CR) with a remarkably low 2-year non relapse mortality (NRM) and satisfactory disease control. Based on these data a randomized phase 3 trial for patients with AML in CR≥2 is currently being conducted by the Cooperative German Transplant Study Group comparing TBI 8 Gy/fludarabine to conventionally dosed conditioning with TBI 12 Gy/cyclophosphamide.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Procedure: conditioning for allogeneic HSCT Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase 3 Trial for Patients With AML in CR2 Comparing Total Body Irradiation (TBI) With 8Gy/Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide
Study Start Date : October 2004
Primary Completion Date : July 2011
Study Completion Date : July 2011

Arms and Interventions

Arm Intervention/treatment
Active Comparator: conditioning therapy with 12 Gy TBI / cyclophosphamide 120 Procedure: conditioning for allogeneic HSCT
Experimental: conditioning therapy with 8 Gy TBI / fludarabine 120 Procedure: conditioning for allogeneic HSCT

Outcome Measures

Primary Outcome Measures :
  1. treatment related mortality

Secondary Outcome Measures :
  1. event free survival
  2. overall survival
  3. cumulative incidence of acute and chronic graft-versus-host disease (GvHD)
  4. activity index (ECOG)
  5. organ function

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with AML in second complete remission
  • HLA-identical related (HLA * A, B, and DR) or HLA-compatible unrelated donor with maximum of one Ag mismatch
  • Ages 18-60 years
  • Written informed consent from the patient
  • Written informed consent from the donor
  • No major organ dysfunction

Exclusion Criteria:

  • Cardiac failure (New York Heart Association [NYHA] grade II-IV)
  • Renal failure (creatinine > 2.0 mg/dl)
  • Hepatic failure (total bilirubin > 3 mg/dl)
  • Severe neurological/psychiatric disorder
  • Previous allogeneic HSCT
  • Contra-indications for used drugs
  • HIV infection
  • Non-compliance to processing of personal data according to the protocol
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125606

Department of Medicine/Hematology and Oncology
Muenster, NRW, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Technische Universität Dresden
Philipps University Marburg Medical Center
Universitätsklinikum Hamburg-Eppendorf
Hannover Medical School
Ludwig-Maximilians - University of Munich
University Hospital, Essen
Johann Wolfgang Goethe University Hospital
Deutsche Klinik fuer Diagnostik
Charite University, Berlin, Germany
Principal Investigator: Matthias Stelljes, M.D. Department of Medicine/Hematology and Oncology
More Information

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00125606     History of Changes
Other Study ID Numbers: AML_CR2_allo_HSCT
First Posted: August 1, 2005    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by University Hospital Muenster:
allogeneic HSCT
reduced intensity conditioning
randomized trail

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic