HCT Versus CT in Elderly AML

Phase 3

Terminated

• Conditions: Acute Myeloid Leukemia
• Interventions: Procedure: hematopoietic cell transplantation; Drug: Non-Transplant treatment approach for consolidation

• Registration Number: NCT00766779
• Lead Sponsor: European Society for Blood and Marrow Transplantation

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

Study Timeline

• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Study First Posted: 2008-10-06
• Study Start: 2010-01
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transplant Arm	hematopoietic cell transplantation	Hematopoietic cell transplantation after Reduced Intensity Conditioning
Conventional Chemotherapy	Non-Transplant treatment approach for consolidation	The non-transplant treatment approach for consolidation

Primary Outcome Measures

Name	Time	Method
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	5 years

Secondary Outcome Measures

Name	Time	Method
To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT	5 Years

Trial Locations

Locations (47)

CHUV Lausanne; 🇨🇭 Lausanne, Switzerland

Kantonsspital Luzern; 🇨🇭 Luzern 16, Switzerland

Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität; 🇩🇪 Magdeburg, Germany

University Regensburg; 🇩🇪 Regensburg, Germany

Universität Tübingen; 🇩🇪 Tübingen, Germany

University Hospital; 🇨🇭 Basel, Switzerland

Academisch Ziekenhuis bij de Universiteit Amsterdam; 🇳🇱 Amsterdam, Netherlands

University Hospital Zürich; 🇨🇭 Zürich, Switzerland

Klinik für Innere Medizin C; 🇩🇪 Greifswald, Germany

University of Heidelberg; 🇩🇪 Heidelberg, Germany

Friedrich-Schiller-Universität Jena; 🇩🇪 Jena, Germany

The Alfred Hospital; 🇦🇺 Melbourne Victoria, Australia

Medizinische Universität Wien; 🇦🇹 Wien, Austria

ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen; 🇧🇪 Antwerpen, Belgium

Centre Hospitalier Sud Amiens; 🇫🇷 Amiens cedex 1, France

Hopital Femme Enfant Hématologie; 🇫🇷 Caen Cedex 9, France

Hôpital d'instruction des armées Percy; 🇫🇷 Clamart, France

Centre hospitalier et universitaire (CHU) d´ Estaing; 🇫🇷 Clermont-Ferrand, France

Institut Paoli-Calmettes; 🇫🇷 Marseille cedex 9, France

CHU de Nantes, Hôtel Dieu; 🇫🇷 Nantes cedex 01, France

Centre hospitalier et universitaire (CHU) de Nice; 🇫🇷 Nice, France

Hopital Saint Antoine; 🇫🇷 Paris 12ème, France

CHU du Haut Lévêque; 🇫🇷 Pessac, France

II. Medizinische Klinik, Hämatologie/Internistische Onkologie; 🇩🇪 Augsburg, Germany

Charité - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Germany

Universitaetsklinikum Dresden; 🇩🇪 Dresden, Germany

Centre hospitalier et universitaire (CHU) de Limoges; 🇫🇷 Limoges cedex, France

Centre Antoine Lacassagne; 🇫🇷 Nice cedex 2, France

Centre Hospitalier (CH) Saint Quentin; 🇫🇷 Saint Quentin cedex, France

Hanusch Krankenhaus der Wiener Gebietskrankenkasse; 🇦🇹 Wien, Austria

UZ Gasthuisberg Leuven; 🇧🇪 Leuven, Belgium

University Hospital Maastricht; 🇳🇱 Maastricht, Netherlands

Inselspital Bern; 🇨🇭 Bern, Switzerland

VU University Medical Center Amsterdam; 🇳🇱 Amsterdam, Netherlands

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands

University Medical Centre Utrecht; 🇳🇱 Utrecht, Netherlands

Isala klinieken; 🇳🇱 Zwolle, Netherlands

Erasmus MC-Daniel den Hoed Cancer Centre; 🇳🇱 Rotterdam, Netherlands

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland

Hopitaux Universitaires de Geneve; 🇨🇭 Geneve, Switzerland

University of Münster; 🇩🇪 Münster, Germany

University Aachen; 🇩🇪 Aachen, Germany

Klinikum Ernst von Bergmann gGmbH; 🇩🇪 Potsdam, Germany

Universität Rostock; 🇩🇪 Rostock, Germany

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany

Allogeneic Stem Cell Transplant Cente; 🇩🇪 Würzburg, Germany