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

Last updated: October 28, 2021
Sponsor: University Hospital Carl Gustav Carus
Overall Status: Terminated

Phase

3

Condition

Leukemia

Treatment

N/A

Clinical Study ID

NCT01246752
TUD-ETAL-1-045
  • Ages 18-60
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

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 ± onesingle additional aberration
  • pregnancy / nursing
  • non-compliance

Study Design

Total Participants: 143
Study Start date:
February 10, 2011
Estimated Completion Date:
April 30, 2020

Connect with a study center

  • Universitätsklinikum Aachen

    Aachen,
    Germany

    Site Not Available

  • Klinikum Augsburg

    Augsburg,
    Germany

    Site Not Available

  • Bielefeld Klinikum Mitte

    Bielefeld,
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH

    Chemnitz,
    Germany

    Site Not Available

  • University Hospital Carl Gustav Carus

    Dresden, 01307
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen,
    Germany

    Site Not Available

  • Universitätsklinikum Essen - Westdeutsches Tumorzentrum

    Essen,
    Germany

    Site Not Available

  • Klinikum der Johann-Wolfgang-Goethe Universität

    Frankfurt am Main,
    Germany

    Site Not Available

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt/Oder,
    Germany

    Site Not Available

  • Ernst-Moritz-Arndt-Universitaet Greifswald

    Greifswald,
    Germany

    Site Not Available

  • Universitätsklinikum Halle

    Halle / Saale,
    Germany

    Site Not Available

  • Asklepios Klinik St. Georg

    Hamburg,
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg,
    Germany

    Site Not Available

  • Universitaetsklinikum Leipzig - AöR

    Leipzig,
    Germany

    Site Not Available

  • Universitätsklinikum Magdeburg

    Magdeburg,
    Germany

    Site Not Available

  • Universitätsklinikum Mannheim

    Mannheim,
    Germany

    Site Not Available

  • Universitätsklinikum Gießen und Marburg GmbH

    Marburg,
    Germany

    Site Not Available

  • Klinikum der LMU Universität - Campus Großhadern

    München,
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster,
    Germany

    Site Not Available

  • Klinikum der LMU Universität - Campus Großhadern

    München,
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster,
    Germany

    Site Not Available

  • Städtisches Klinikum Nord

    Nürnberg,
    Germany

    Site Not Available

  • Städtisches Klinikum Nord

    Nürnberg,
    Germany

    Site Not Available

  • Ernst-von-Bergmann-Klinikum Potsdam

    Potsdam,
    Germany

    Site Not Available

  • Klinikum der Universität Regensburg

    Regensburg,
    Germany

    Site Not Available

  • Robert-Bosch-Krankenhaus

    Stuttgart,
    Germany

    Site Not Available

  • Klinikum Mutterhaus der Borromäerinnen gGmbH

    Trier,
    Germany

    Site Not Available

  • Dt. Klinik für Diagnostik

    Wiesbaden,
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg,
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg,
    Germany

    Site Not Available

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