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

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ClinicalTrials.gov Identifier: NCT00150878
Recruitment Status : Terminated (Insurance coverage reached)
First Posted : September 8, 2005
Last Update Posted : June 20, 2013
Sponsor:
Information provided by:
University Hospital Carl Gustav Carus

Tracking Information
First Submitted Date  ICMJE September 6, 2005
First Posted Date  ICMJE September 8, 2005
Last Update Posted Date June 20, 2013
Study Start Date  ICMJE December 2003
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2011)
Treatment-related mortality at 12 months after transplantation [ Time Frame: 12 months ]
Proportion of patients dying without prior relapse
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2005)
Treatment-related mortality at 12 months after transplantation
Change History Complete list of historical versions of study NCT00150878 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2011)
  • Disease-free and Overall survival [ Time Frame: 5 years ]
    Proportion of patients alive without relapse
  • Grade 3-4 extramedullary toxicity [ Time Frame: 100 days ]
    Percentage of patients with grade II-IV acute GvHD
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2005)
  • Disease-free and Overall survival
  • Grade II-IV acute Graft-versus-Host disease
  • Grade 3-4 extramedullary toxicity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standard vs. Reduced-Intensity Conditioning in Patients With Acute Myeloid Leukemia in First Remission
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE Other: Conditioning therapy
Preparation before allogeneic transplantation
Study Arms  ICMJE
  • 12 Gy/Cyclophosphamide
    Standard intensity conditioning
    Intervention: Other: Conditioning therapy
  • Experimental: 8 Gy /Fludarabine
    Reduced-intensity conditioning
    Intervention: Other: Conditioning therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 6, 2011)
198
Original Enrollment  ICMJE
 (submitted: September 6, 2005)
172
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00150878
Other Study ID Numbers  ICMJE 9005-2003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Dresden
Study Sponsor  ICMJE University Hospital Carl Gustav Carus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gerhard Ehninger, MD Director of Med. Klink und Poliklinik I, Technical University Dresden
PRS Account University Hospital Carl Gustav Carus
Verification Date June 2013

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