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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00150878
Recruitment Status : Terminated (Insurance coverage reached)
First Posted : September 8, 2005
Last Update Posted : June 20, 2013
Information provided by:
University Hospital Carl Gustav Carus

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Other: Conditioning therapy Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2003
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Arm Intervention/treatment
12 Gy/Cyclophosphamide
Standard intensity conditioning
Other: Conditioning therapy
Preparation before allogeneic transplantation

Experimental: 8 Gy /Fludarabine
Reduced-intensity conditioning
Other: Conditioning therapy
Preparation before allogeneic transplantation

Primary Outcome Measures :
  1. Treatment-related mortality at 12 months after transplantation [ Time Frame: 12 months ]
    Proportion of patients dying without prior relapse

Secondary Outcome Measures :
  1. Disease-free and Overall survival [ Time Frame: 5 years ]
    Proportion of patients alive without relapse

  2. Grade 3-4 extramedullary toxicity [ Time Frame: 100 days ]
    Percentage of patients with grade II-IV acute GvHD

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00150878

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Medizinische Klinik und Poliklinik I
Dresden, Germany, 01307
Sponsors and Collaborators
University Hospital Carl Gustav Carus
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Study Director: Gerhard Ehninger, MD Director of Med. Klink und Poliklinik I, Technical University Dresden

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital Dresden Identifier: NCT00150878     History of Changes
Other Study ID Numbers: 9005-2003
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2013

Keywords provided by University Hospital Carl Gustav Carus:
Reduced-intensity conditioning
Acute myeloid Leukemia
Treatment-related mortality

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