HCT Versus CT in Elderly AML

Last updated: October 6, 2021
Sponsor: European Society for Blood and Marrow Transplantation
Overall Status: Terminated

Phase

3

Condition

Leukemia

Acute Myeloid Leukemia

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT00766779
2007-003514-34
EBMT-ALWP01/2008
  • Ages 60-75
  • All Genders

Study Summary

A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 60years and ≤ 75 years
  • primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
  • First complete remission following one or two cycles of induction chemotherapy
  • Chemotherapy was administered according to current participating cooperative groupprotocols
  • Karnofsky score ≥ 70
  • Written informed consent

Exclusion

Exclusion Criteria:

  • AML FAB M3
  • HIV positivity
  • Participation in another clinical trial without prior consent of the coordinatinginvestigator, patients may exceptionally take part in a further study only if
  • The second study exclusively concerns induction therapy
  • Consolidation cycle one and two are given according to the accredited study grouppolicy
  • No investigational drugs are used post registration for the HCT vs CT in elderyAML study.
  • Documentation for the HCT vs CT in eldery AML study is not compromised. Secondhand data from foreign study is not accepted

Study Design

Total Participants: 126
Study Start date:
January 01, 2010
Estimated Completion Date:
December 31, 2020

Study Description

The majority of patients with acute myelogenous leukaemia (AML) enter complete remission following induction therapy, but relapse despite consolidation and maintenance therapy. In response, post-remission treatment has been progressively intensified and results improved either by high-dose post-remission therapy with autologous hematopoietic cell transplantation (HCT) or by allogeneic HCT, which has the highest curative potential for patients with AML. Given the toxicity of dose intensification and of allogeneic HCT, however, only younger patients profit from this treatment approach

Connect with a study center

  • The Alfred Hospital

    Melbourne Victoria,
    Australia

    Site Not Available

  • Hanusch Krankenhaus der Wiener Gebietskrankenkasse

    Wien,
    Austria

    Site Not Available

  • Medizinische Universität Wien

    Wien,
    Austria

    Site Not Available

  • ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen

    Antwerpen,
    Belgium

    Site Not Available

  • UZ Gasthuisberg Leuven

    Leuven,
    Belgium

    Site Not Available

  • Centre Hospitalier Sud Amiens

    Amiens cedex 1,
    France

    Site Not Available

  • Centre hospitalier et universitaire (CHU) d´Angers

    Angers,
    France

    Site Not Available

  • Centre hospitalier Victor Dupouy

    Argenteuil,
    France

    Site Not Available

  • Hôpital Jean Minjoz

    Besançon cedex,
    France

    Site Not Available

  • Centre hospitalier et universitaire (CHU) de Brest, Hôpital Morvan

    Brest cedex,
    France

    Site Not Available

  • Hopital Henri Mondor

    CRETEIL Cedex,
    France

    Site Not Available

  • Hopital Femme Enfant Hématologie

    Caen Cedex 9,
    France

    Site Not Available

  • Hôpital d'instruction des armées Percy

    Clamart,
    France

    Site Not Available

  • Centre hospitalier et universitaire (CHU) d´ Estaing

    Clermont-Ferrand,
    France

    Site Not Available

  • Centre Hospitalier Sud Francilien

    Corbeil essonnes cedex,
    France

    Site Not Available

  • Hopital d'enfants

    Dijon,
    France

    Site Not Available

  • Centre Hospitalier de VERSAILLES

    Le Chesnay cedex,
    France

    Site Not Available

  • Centre hospitalier et universitaire (CHU) de Limoges

    Limoges cedex,
    France

    Site Not Available

  • Institut Paoli-Calmettes

    Marseille cedex 9,
    France

    Site Not Available

  • CHU de Nantes, Hôtel Dieu

    Nantes cedex 01,
    France

    Site Not Available

  • Centre hospitalier et universitaire (CHU) de Nice

    Nice,
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice cedex 2,
    France

    Site Not Available

  • Hospital Saint-Louis

    Paris, 75010
    France

    Site Not Available

  • Hopital Saint Antoine

    Paris 12ème,
    France

    Site Not Available

  • Hopital Saint Louis

    Paris cedex 10,
    France

    Site Not Available

  • Hopital Necker

    Paris cedex 15,
    France

    Site Not Available

  • CHU du Haut Lévêque

    Pessac,
    France

    Site Not Available

  • Hôpital de Pontchaillou

    Rennes,
    France

    Site Not Available

  • Centre Hospitalier (CH) Saint Quentin

    Saint Quentin cedex,
    France

    Site Not Available

  • Hôpital Hautepierre

    Strasbourg cedex,
    France

    Site Not Available

  • University Aachen

    Aachen,
    Germany

    Site Not Available

  • II. Medizinische Klinik, Hämatologie/Internistische Onkologie

    Augsburg,
    Germany

    Site Not Available

  • Charité - Campus Benjamin Franklin

    Berlin,
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH

    Chemnitz,
    Germany

    Site Not Available

  • Universitaetsklinikum Dresden

    Dresden,
    Germany

    Site Not Available

  • Klinik für Innere Medizin C

    Greifswald,
    Germany

    Site Not Available

  • University of Heidelberg

    Heidelberg,
    Germany

    Site Not Available

  • Friedrich-Schiller-Universität Jena

    Jena,
    Germany

    Site Not Available

  • University Hospital

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität

    Magdeburg,
    Germany

    Site Not Available

  • University of Münster

    Münster,
    Germany

    Site Not Available

  • University of Münster

    Münster,
    Germany

    Site Not Available

  • Klinikum Ernst von Bergmann gGmbH

    Potsdam,
    Germany

    Site Not Available

  • University Regensburg

    Regensburg,
    Germany

    Site Not Available

  • Universität Rostock

    Rostock,
    Germany

    Site Not Available

  • Robert-Bosch-Krankenhaus

    Stuttgart,
    Germany

    Site Not Available

  • Universität Tübingen

    Tübingen,
    Germany

    Site Not Available

  • Universität Tübingen

    Tübingen,
    Germany

    Site Not Available

  • Allogeneic Stem Cell Transplant Cente

    Würzburg,
    Germany

    Site Not Available

  • Allogeneic Stem Cell Transplant Cente

    Würzburg,
    Germany

    Site Not Available

  • Academisch Ziekenhuis bij de Universiteit Amsterdam

    Amsterdam,
    Netherlands

    Site Not Available

  • VU University Medical Center Amsterdam

    Amsterdam,
    Netherlands

    Site Not Available

  • University Medical Centre Groningen

    Groningen,
    Netherlands

    Site Not Available

  • University Hospital Maastricht

    Maastricht,
    Netherlands

    Site Not Available

  • Erasmus MC-Daniel den Hoed Cancer Centre

    Rotterdam, 3008
    Netherlands

    Site Not Available

  • University Medical Centre Utrecht

    Utrecht,
    Netherlands

    Site Not Available

  • Isala klinieken

    Zwolle,
    Netherlands

    Site Not Available

  • Kantonsspital Aarau

    Aarau,
    Switzerland

    Site Not Available

  • University Hospital

    Basel, 4031
    Switzerland

    Site Not Available

  • Inselspital Bern

    Bern,
    Switzerland

    Site Not Available

  • Hopitaux Universitaires de Geneve

    Geneve, 1211
    Switzerland

    Site Not Available

  • CHUV Lausanne

    Lausanne,
    Switzerland

    Site Not Available

  • Kantonsspital Luzern

    Luzern 16,
    Switzerland

    Site Not Available

  • University Hospital Zürich

    Zürich,
    Switzerland

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.