Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI /Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide
This study is currently recruiting participants.
Verified by University Hospital Muenster, April 2007
Sponsors and Collaborators: University Hospital Muenster
Dresden University of Technology
Philipps University Marburg Medical Center
Center of Hematology/Oncology and Bone Marrow Transplantation, Idar-Oberstein
Universitätsklinikum Hamburg-Eppendorf
Hannover Medical School
Ludwig-Maximilians - University of Munich
University Hospital, Essen
Johann Wolfgang Goethe University Hospitals
Deutsche Klinik für Diagnostik, KMT Zentrum, Wiesbaden
Charite University, Berlin, Germany
Information provided by: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00125606
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
Procedure: conditioning for allogeneic HSCT
Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized Phase 3 Trial for Patients With AML in CR2 Comparing TBI 8Gy/Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • treatment related mortality

Secondary Outcome Measures:
  • event free survival
  • overall survival
  • cumulative incidence of acute and chronic graft-versus-host disease (GvHD)
  • activity index (ECOG)
  • organ function

Estimated Enrollment: 172
Study Start Date: October 2004
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125606

Locations
Germany, NRW
Department of Medicine/Hematology and Oncology Recruiting
Muenster, NRW, Germany, 48149
Contact: Matthias Stelljes, M.D.     +49 251 83-52801     stelljes@uni-muenster.de    
Principal Investigator: Matthias Stelljes, M.D.            
Sponsors and Collaborators
University Hospital Muenster
Dresden University of Technology
Philipps University Marburg Medical Center
Center of Hematology/Oncology and Bone Marrow Transplantation, Idar-Oberstein
Universitätsklinikum Hamburg-Eppendorf
Hannover Medical School
Ludwig-Maximilians - University of Munich
University Hospital, Essen
Johann Wolfgang Goethe University Hospitals
Deutsche Klinik für Diagnostik, KMT Zentrum, Wiesbaden
Charite University, Berlin, Germany
Investigators
Principal Investigator: Matthias Stelljes, M.D. Department of Medicine/Hematology and Oncology
  More Information

Responsible Party: University of Muenster ( University of Muenster )
Study ID Numbers: AML_CR2_allo_HSCT
Study First Received: July 26, 2005
Last Updated: June 3, 2008
ClinicalTrials.gov Identifier: NCT00125606  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Study placed in the following topic categories:
Leukemia
Acute myelogenous leukemia
Fludarabine
Fludarabine monophosphate
Cyclophosphamide
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009