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

This study has been terminated.
(insufficient patient recruitement)
Sponsor:
Collaborators:
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 Hospitals
Deutsche Klinik fuer Diagnostik
Charite University, Berlin, Germany
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00125606
First received: July 26, 2005
Last updated: December 17, 2012
Last verified: December 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Enrollment: 30
Study Start Date: October 2004
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
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 Hospitals
Deutsche Klinik fuer Diagnostik
Charite University, Berlin, Germany
Investigators
Principal Investigator: Matthias Stelljes, M.D. Department of Medicine/Hematology and Oncology
  More Information

No publications provided

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00125606     History of Changes
Other Study ID Numbers: AML_CR2_allo_HSCT
Study First Received: July 26, 2005
Last Updated: December 17, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on October 19, 2014