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

December 17, 2012 updated by: University Hospital Muenster

Randomized Phase 3 Trial for Patients With AML in CR2 Comparing Total Body Irradiation (TBI) With 8Gy/Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Muenster, NRW, Germany, 48149
        • Department of Medicine/Hematology and Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
treatment related mortality

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Collaborators

Charite University, Berlin, Germany
Hannover Medical School
University Hospital, Essen
Ludwig-Maximilians - University of Munich
Johann Wolfgang Goethe University Hospital
Technische Universität Dresden
Universitätsklinikum Hamburg-Eppendorf
Philipps University Marburg Medical Center
Deutsche Klinik fuer Diagnostik

Investigators

  • Principal Investigator: Matthias Stelljes, M.D., Department of Medicine/Hematology and Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

July 26, 2005

First Submitted That Met QC Criteria

July 29, 2005

First Posted (Estimate)

August 1, 2005

Study Record Updates

Last Update Posted (Estimate)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 17, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AML_CR2_allo_HSCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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