Standard vs. Reduced-Intensity Conditioning in Patients With Acute Myeloid Leukemia in First Remission

This study has been terminated.
(Insurance coverage reached)
Sponsor:
Information provided by:
University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier:
NCT00150878
First received: September 6, 2005
Last updated: June 19, 2013
Last verified: June 2013

September 6, 2005
June 19, 2013
December 2003
December 2009   (final data collection date for primary outcome measure)
Treatment-related mortality at 12 months after transplantation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Proportion of patients dying without prior relapse
Treatment-related mortality at 12 months after transplantation
Complete list of historical versions of study NCT00150878 on ClinicalTrials.gov Archive Site
  • Disease-free and Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of patients alive without relapse
  • Grade 3-4 extramedullary toxicity [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    Percentage of patients with grade II-IV acute GvHD
  • Disease-free and Overall survival
  • Grade II-IV acute Graft-versus-Host disease
  • Grade 3-4 extramedullary toxicity
Not Provided
Not Provided
 
Standard vs. Reduced-Intensity Conditioning in Patients With Acute Myeloid Leukemia in First Remission
Randomized Phase III Comparison of 12 Gy TBI and Cyclophosphamide 120 mg/kg With Fludarabine 120 mg/Sqm and 8 Gy TBI Before Allogeneic Transplantation in Patients With Acute Myeloid Leukemia in First Remission

The primary goal of the study is to show that the treatment-related mortality of allogeneic hematopoietic stem cell transplantation an be significantly reduced by using a combination of 8 Gy total-body-irradiation and fludarabine in comparison to the conventional combination of 12 Gy TBI and 120 mg/kg Cyclophosphamide.

Transplant-related deaths because of extramedullary toxicity and graft-versus host disease remain the major causes for treatment-failure in patients with AMl receiving allogeneic hematopoietic stem cell transplantation.

In phase II study, M . Stelljes and coworkers could show, that a reduced dose of total-body- irradiation and fludarabine can be safely used in patients with AML at various disease stages. The best results could be achieved in patients who had been in complete remission by the time of inclusion.

Therefore this prospective trial was initiated to compare the new conditioning regimen with the standard regimen of 12 Gy TBI/Cyclophosphamide 120 mg/kg in patients ith AML in first remission.

After having achieved complete remission, and giving informed consent, patients are stratified according to marrow cytogenetics, age and type of induction therapy and subsequently randomized to receive on of the mentioned conditioning therapies.

The primary end-point will be non-relapse mortality. The hypothesis would be, that the one-year mortality can be reduced from 25 to 15%. Given a power of 0.8 and a first-error of 5%, 252 patients will have to be randomized.

Secondary endpoints include:

3 year overall-and disease-free survival Rate of grade II-IV acute GvHD Rate of grade 3-4 extramedullary toxicity

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
Other: Conditioning therapy
Preparation before allogeneic transplantation
  • 12 Gy/Cyclophosphamide
    Standard intensity conditioning
    Intervention: Other: Conditioning therapy
  • Experimental: 8 Gy /Fludarabine
    Reduced-intensity conditioning
    Intervention: Other: Conditioning therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
198
December 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of acute myeloid leukemia in first remission
  • Standard-or high-risk marrow cytogenetics
  • HLA-matched related or unrelated donor available (in case of high-risk disease)
  • Age 18 to 60
  • Informed consent
  • Consent of donor to donate peripheral blood stem cells
  • sufficient liver function (elevation of transferases < 2.5 x upper limit)

Exclusion Criteria:

  • AML with t(5;17)
  • AML with t((8;21)
  • clinically relevant heart failure (NYHA II-IV)
  • Renal failure (creatinine > 200 µg/ml)
  • Liver function failure (bilirubin > 3 mg/dl)
  • Concomitant Neurological or psychiatric disease
  • Contraindications to receive prescribed study medication
  • HIV infection
  • Pregnancy
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00150878
9005-2003
Yes
University Hospital Dresden
University Hospital Carl Gustav Carus
Not Provided
Study Director: Gerhard Ehninger, MD Director of Med. Klink und Poliklinik I, Technical University Dresden
University Hospital Carl Gustav Carus
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP