HCT Versus CT in Elderly AML

October 6, 2021 updated by: European Society for Blood and Marrow Transplantation

Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne Victoria, Australia
        • The Alfred Hospital
  • Austria
      • Wien, Austria
        • Hanusch Krankenhaus der Wiener Gebietskrankenkasse
      • Wien, Austria
        • Medizinische Universität Wien
  • Belgium
      • Antwerpen, Belgium
        • ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen
      • Leuven, Belgium
        • UZ Gasthuisberg Leuven
  • France
      • Amiens cedex 1, France
        • Centre Hospitalier Sud Amiens
      • Caen Cedex 9, France
        • Hopital Femme Enfant Hématologie
      • Clamart, France
        • Hôpital d'Instruction des Armées PERCY
      • Clermont-Ferrand, France
        • Centre hospitalier et universitaire (CHU) d´ Estaing
      • Limoges cedex, France
        • Centre hospitalier et universitaire (CHU) de Limoges
      • Marseille cedex 9, France
        • Institut Paoli-Calmettes
      • Nantes cedex 01, France
        • CHU de Nantes, Hotel Dieu
      • Nice, France
        • Centre hospitalier et universitaire (CHU) de Nice
      • Nice cedex 2, France
        • Centre Antoine Lacassagne
      • Paris 12ème, France
        • Hôpital Saint Antoine
      • Pessac, France
        • CHU du Haut Leveque
      • Saint Quentin cedex, France
        • Centre Hospitalier (CH) Saint Quentin
  • Germany
      • Aachen, Germany
        • University Aachen
      • Augsburg, Germany
        • II. Medizinische Klinik, Hämatologie/Internistische Onkologie
      • Berlin, Germany
        • Charite - Campus Benjamin Franklin
      • Chemnitz, Germany
        • Klinikum Chemnitz gGmbH
      • Dresden, Germany
        • Universitaetsklinikum Dresden
      • Greifswald, Germany
        • Klinik für Innere Medizin C
      • Heidelberg, Germany
        • University of Heidelberg
      • Jena, Germany
        • Friedrich-Schiller-Universitat Jena
      • Leipzig, Germany, 04103
        • University Hospital
      • Magdeburg, Germany
        • Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität
      • Münster, Germany
        • University of Münster
      • Potsdam, Germany
        • Klinikum Ernst von Bergmann gGmbH
      • Regensburg, Germany
        • University Regensburg
      • Rostock, Germany
        • Universität Rostock
      • Stuttgart, Germany
        • Robert-Bosch-Krankenhaus
      • Tübingen, Germany
        • Universitat Tubingen
      • Würzburg, Germany
        • Allogeneic Stem Cell Transplant Cente
  • Netherlands
      • Amsterdam, Netherlands
        • Academisch Ziekenhuis bij de Universiteit Amsterdam
      • Amsterdam, Netherlands
        • VU University Medical Center Amsterdam
      • Groningen, Netherlands
        • University Medical Centre Groningen
      • Maastricht, Netherlands
        • University Hospital Maastricht
      • Rotterdam, Netherlands, 3008
        • Erasmus MC-Daniel den Hoed Cancer Centre
      • Utrecht, Netherlands
        • University Medical Centre Utrecht
      • Zwolle, Netherlands
        • Isala Klinieken
  • Switzerland
      • Aarau, Switzerland
        • Kantonsspital Aarau
      • Basel, Switzerland, 4031
        • University Hospital
      • Bern, Switzerland
        • Inselspital Bern
      • Geneve, Switzerland, 1211
        • Hôpitaux Universitaires de Genève
      • Lausanne, Switzerland
        • CHUV Lausanne
      • Luzern 16, Switzerland
        • Kantonsspital Luzern
      • Zürich, Switzerland
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 group protocols
  • Karnofsky score ≥ 70
  • Written informed consent

Exclusion Criteria:

  • AML FAB M3
  • HIV positivity

  • Participation in another clinical trial without prior consent of the coordinating investigator, 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 group policy
    • No investigational drugs are used post registration for the HCT vs CT in eldery AML study.
    • Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transplant Arm
Hematopoietic cell transplantation after Reduced Intensity Conditioning
Procedure: hematopoietic cell transplantation
low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors
Active Comparator: Conventional Chemotherapy
The non-transplant treatment approach for consolidation
Drug: Non-Transplant treatment approach for consolidation
Patients will receive the treatment that would be otherwise applied at the local institution. The consolidation or maintenance therapy is according to the study group protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate Leukaemia Free Survival (LFS) after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT
Time Frame: 5 Years
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Society for Blood and Marrow Transplantation

Collaborators

European Organisation for Research and Treatment of Cancer - EORTC
Swiss Group for Clinical Cancer Research
French Innovative Leukemia Organisation
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Acute Leukemia French Association
HOVON - Dutch Haemato-Oncology Association
East German Study Group of Hematology and Oncology (OSHO)

Investigators

  • Study Chair: Dietger Niederwieser, Prof, EBMT and OSHO
  • Study Chair: Bob Löwenberg, Prof, Stichting Hemato-Oncologie voor Volwassenen Nederland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 3, 2008

First Posted (Estimate)

October 6, 2008

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-003514-34
  • EBMT-ALWP01/2008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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