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HCT Versus CT in Elderly AML

Primary Purpose

Acute Myeloid Leukemia

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
hematopoietic cell transplantation
Non-Transplant treatment approach for consolidation
Sponsored by
European Society for Blood and Marrow Transplantation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring hematopoietic cell transplantation, Acute Myeloid Leukemia, first Complete Remission

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Alfred Hospital
  • Hanusch Krankenhaus der Wiener Gebietskrankenkasse
  • Medizinische Universität Wien
  • ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen
  • UZ Gasthuisberg Leuven
  • Centre Hospitalier Sud Amiens
  • Hopital Femme Enfant Hématologie
  • Hôpital d'instruction des armées Percy
  • Centre hospitalier et universitaire (CHU) d´ Estaing
  • Centre hospitalier et universitaire (CHU) de Limoges
  • Institut Paoli-Calmettes
  • CHU de Nantes, Hôtel Dieu
  • Centre Antoine Lacassagne
  • Centre hospitalier et universitaire (CHU) de Nice
  • Hopital Saint Antoine
  • CHU du Haut Lévêque
  • Centre Hospitalier (CH) Saint Quentin
  • University Aachen
  • II. Medizinische Klinik, Hämatologie/Internistische Onkologie
  • Charité - Campus Benjamin Franklin
  • Klinikum Chemnitz gGmbH
  • Universitaetsklinikum Dresden
  • Klinik für Innere Medizin C
  • University of Heidelberg
  • Friedrich-Schiller-Universität Jena
  • University Hospital
  • Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität
  • University of Münster
  • Klinikum Ernst von Bergmann gGmbH
  • University Regensburg
  • Universität Rostock
  • Robert-Bosch-Krankenhaus
  • Universität Tübingen
  • Allogeneic Stem Cell Transplant Cente
  • Academisch Ziekenhuis bij de Universiteit Amsterdam
  • VU University Medical Center Amsterdam
  • University Medical Centre Groningen
  • University Hospital Maastricht
  • Erasmus MC-Daniel den Hoed Cancer Centre
  • University Medical Centre Utrecht
  • Isala klinieken
  • Kantonsspital Aarau
  • University Hospital
  • Inselspital Bern
  • Hopitaux Universitaires de Geneve
  • CHUV Lausanne
  • Kantonsspital Luzern
  • University Hospital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transplant Arm

Conventional Chemotherapy

Arm Description

Hematopoietic cell transplantation after Reduced Intensity Conditioning

The non-transplant treatment approach for consolidation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT

Full Information

First Posted
October 3, 2008
Last Updated
October 6, 2021
Sponsor
European Society for Blood and Marrow Transplantation
Collaborators
Acute Leukemia French Association, Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias, European Organisation for Research and Treatment of Cancer - EORTC, French Innovative Leukemia Organisation, HOVON - Dutch Haemato-Oncology Association, East German Study Group of Hematology and Oncology (OSHO), Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00766779
Brief Title
HCT Versus CT in Elderly AML
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Recommendation of DMC
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Society for Blood and Marrow Transplantation
Collaborators
Acute Leukemia French Association, Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias, European Organisation for Research and Treatment of Cancer - EORTC, French Innovative Leukemia Organisation, HOVON - Dutch Haemato-Oncology Association, East German Study Group of Hematology and Oncology (OSHO), Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
hematopoietic cell transplantation, Acute Myeloid Leukemia, first Complete Remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transplant Arm
Arm Type
Experimental
Arm Description
Hematopoietic cell transplantation after Reduced Intensity Conditioning
Arm Title
Conventional Chemotherapy
Arm Type
Active Comparator
Arm Description
The non-transplant treatment approach for consolidation
Intervention Type
Procedure
Intervention Name(s)
hematopoietic cell transplantation
Intervention Description
low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors
Intervention Type
Drug
Intervention Name(s)
Non-Transplant treatment approach for consolidation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT
Time Frame
5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dietger Niederwieser, Prof
Organizational Affiliation
EBMT and OSHO
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bob Löwenberg, Prof
Organizational Affiliation
Stichting Hemato-Oncologie voor Volwassenen Nederland
Official's Role
Study Chair
Facility Information:
Facility Name
The Alfred Hospital
City
Melbourne Victoria
Country
Australia
Facility Name
Hanusch Krankenhaus der Wiener Gebietskrankenkasse
City
Wien
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
Country
Austria
Facility Name
ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen
City
Antwerpen
Country
Belgium
Facility Name
UZ Gasthuisberg Leuven
City
Leuven
Country
Belgium
Facility Name
Centre Hospitalier Sud Amiens
City
Amiens cedex 1
Country
France
Facility Name
Hopital Femme Enfant Hématologie
City
Caen Cedex 9
Country
France
Facility Name
Hôpital d'instruction des armées Percy
City
Clamart
Country
France
Facility Name
Centre hospitalier et universitaire (CHU) d´ Estaing
City
Clermont-Ferrand
Country
France
Facility Name
Centre hospitalier et universitaire (CHU) de Limoges
City
Limoges cedex
Country
France
Facility Name
Institut Paoli-Calmettes
City
Marseille cedex 9
Country
France
Facility Name
CHU de Nantes, Hôtel Dieu
City
Nantes cedex 01
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice cedex 2
Country
France
Facility Name
Centre hospitalier et universitaire (CHU) de Nice
City
Nice
Country
France
Facility Name
Hopital Saint Antoine
City
Paris 12ème
Country
France
Facility Name
CHU du Haut Lévêque
City
Pessac
Country
France
Facility Name
Centre Hospitalier (CH) Saint Quentin
City
Saint Quentin cedex
Country
France
Facility Name
University Aachen
City
Aachen
Country
Germany
Facility Name
II. Medizinische Klinik, Hämatologie/Internistische Onkologie
City
Augsburg
Country
Germany
Facility Name
Charité - Campus Benjamin Franklin
City
Berlin
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
Country
Germany
Facility Name
Universitaetsklinikum Dresden
City
Dresden
Country
Germany
Facility Name
Klinik für Innere Medizin C
City
Greifswald
Country
Germany
Facility Name
University of Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Friedrich-Schiller-Universität Jena
City
Jena
Country
Germany
Facility Name
University Hospital
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität
City
Magdeburg
Country
Germany
Facility Name
University of Münster
City
Münster
Country
Germany
Facility Name
Klinikum Ernst von Bergmann gGmbH
City
Potsdam
Country
Germany
Facility Name
University Regensburg
City
Regensburg
Country
Germany
Facility Name
Universität Rostock
City
Rostock
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
Country
Germany
Facility Name
Universität Tübingen
City
Tübingen
Country
Germany
Facility Name
Allogeneic Stem Cell Transplant Cente
City
Würzburg
Country
Germany
Facility Name
Academisch Ziekenhuis bij de Universiteit Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
VU University Medical Center Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
University Medical Centre Groningen
City
Groningen
Country
Netherlands
Facility Name
University Hospital Maastricht
City
Maastricht
Country
Netherlands
Facility Name
Erasmus MC-Daniel den Hoed Cancer Centre
City
Rotterdam
ZIP/Postal Code
3008
Country
Netherlands
Facility Name
University Medical Centre Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Isala klinieken
City
Zwolle
Country
Netherlands
Facility Name
Kantonsspital Aarau
City
Aarau
Country
Switzerland
Facility Name
University Hospital
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
CHUV Lausanne
City
Lausanne
Country
Switzerland
Facility Name
Kantonsspital Luzern
City
Luzern 16
Country
Switzerland
Facility Name
University Hospital Zürich
City
Zürich
Country
Switzerland

12. IPD Sharing Statement

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HCT Versus CT in Elderly AML

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