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Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) <= 60y. After First CR (AML)

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: NCT01246752
Recruitment Status : Unknown
Verified December 2014 by University Hospital Carl Gustav Carus.
Recruitment status was:  Recruiting
First Posted : November 23, 2010
Last Update Posted : December 3, 2014
German Research Foundation
Information provided by (Responsible Party):
University Hospital Carl Gustav Carus

Brief Summary:
Hematopoietic stem cell transplantation in patients with newly diagnosed AML ≤60 years of age in intermediate risk, after first complete response in comparison to standard consolidation chemotherapy

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Biological: Human Stem Cell Transplantation Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Trial on Allogeneic Haematopoietic Stem Cell Transplantation in Patients Under the Age of 60 Years With Acute Myeloid Leukemia of Intermediate Risk in First Complete Remission and a Matched Sibling or Unrelated Donor (ETAL-1)
Study Start Date : November 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Human Stem Cell Transplantation
Patients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor
Biological: Human Stem Cell Transplantation
Human allogenic stem cells

Active Comparator: Consolidating Chemotherapy
Patients receive a standard chemotherapy as consolidation therapy
Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Consolidation chemotherapy, recommended regimen: HiDAC = 3 x 2g/sqm BID on days 1,3,5

Primary Outcome Measures :
  1. Percent of Patients alive after 4 years (Overall Survival) [ Time Frame: 4 years ]
    The status of each patient alive/not alive is surveyed every 3 months in year 1+2 and every 6 months in year 3+4 after randomisation.

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 4 years ]
  2. Cumulative incidence of relapse [ Time Frame: 4 years ]
  3. Cumulative incidence of non-relapse mortality [ Time Frame: 4 years ]
  4. Quality of life [ Time Frame: 4 years ]

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:

  • AML in first remission
  • cytological standard risk, i.e. karyotype not listed under exclusion criteria
  • Identification of HLA-identical sibling or HLA-compatible related or unrelated donor (9/10 HLA-alleles matched, high resolution typing for HLA-A, B, Cw, DRB1 and DQB1)
  • age: 18 - 60 years
  • medically fit for allogeneic stem cell transplantation
  • CR / CRi after induction therapy

Exclusion Criteria:

  • core-binding factor leukemia (t(8;21), inv16)
  • acute promyelocytic leukemia (t(15;17)
  • complex aberrant karyotype
  • karyotypes: -7; -5; del5q; t(3;3); t(6;11), t(6;9), 11q aberrations, trisomy 8 ± one single additional aberration
  • pregnancy / nursing
  • non-compliance

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): NCT01246752

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Contact: Martin Bornhaeuser, Prof. (MD) +49 (0)351 458-0 ext -4190
Contact: Christoph Roellig, MD +49 (0)351 458-0 ext -3775

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Sponsors and Collaborators
University Hospital Carl Gustav Carus
German Research Foundation
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Principal Investigator: Martin Bornhaeuser, Prof. (MD) Universitätsklinikum Dresden, Medizinische Klinik und Poliklinik I, Germany
Additional Information:
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Responsible Party: University Hospital Carl Gustav Carus Identifier: NCT01246752    
Other Study ID Numbers: TUD-ETAL-1-045
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by University Hospital Carl Gustav Carus:
AML, Leukemia
Acute Myeloid Leukemia
Stem Cell Transplantation
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs