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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)

This study is currently recruiting participants.
Verified December 2014 by University Hospital Carl Gustav Carus
Sponsor:
ClinicalTrials.gov Identifier:
NCT01246752
First Posted: November 23, 2010
Last Update Posted: December 3, 2014
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
University Hospital Carl Gustav Carus
November 22, 2010
November 23, 2010
December 3, 2014
November 2010
December 2017   (Final data collection date for primary outcome measure)
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.
Overall Survival [ Time Frame: 4 years ]
To define the role of allogeneic stem cell transplantation in patients ≤60 years with intermediate-risk acute myeloid leukemia in first complete remission. According to the primary hypothesis, four years after randomisation, a 15% survival advantage of allogeneic stem cell transplantation (60% vs. 45%) compared to conventional postremission therapy is assumed.
Complete list of historical versions of study NCT01246752 on ClinicalTrials.gov Archive Site
  • Disease-free survival [ Time Frame: 4 years ]
  • Cumulative incidence of relapse [ Time Frame: 4 years ]
  • Cumulative incidence of non-relapse mortality [ Time Frame: 4 years ]
  • Quality of life [ Time Frame: 4 years ]
Same as current
Not Provided
Not Provided
 
Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) <= 60y. After First CR
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)
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Leukemia, Myeloid, Acute
  • Biological: Human Stem Cell Transplantation
    Human allogenic stem cells
  • Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
    Consolidation chemotherapy, recommended regimen: HiDAC = 3 x 2g/sqm BID on days 1,3,5
  • Experimental: Human Stem Cell Transplantation
    Patients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor
    Intervention: Biological: Human Stem Cell Transplantation
  • Active Comparator: Consolidating Chemotherapy
    Patients receive a standard chemotherapy as consolidation therapy
    Intervention: Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
356
December 2017
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact: Martin Bornhaeuser, Prof. (MD) +49 (0)351 458-0 ext -4190 martin.bornhaeuser@uniklinikum-dresden.de
Contact: Christoph Roellig, MD +49 (0)351 458-0 ext -3775 christoph.roellig@uniklinikum-dresden.de
Germany
 
 
NCT01246752
TUD-ETAL-1-045
Yes
Not Provided
Not Provided
University Hospital Carl Gustav Carus
University Hospital Carl Gustav Carus
German Research Foundation
Principal Investigator: Martin Bornhaeuser, Prof. (MD) Universitätsklinikum Dresden, Medizinische Klinik und Poliklinik I, Germany
University Hospital Carl Gustav Carus
December 2014

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