HCT Versus CT in Elderly AML
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
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 [5 years]
Secondary Outcome Measures
- To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT [5 Years]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Alfred Hospital | Melbourne Victoria | Australia | ||
| 2 | Hanusch Krankenhaus der Wiener Gebietskrankenkasse | Wien | Austria | ||
| 3 | Medizinische Universität Wien | Wien | Austria | ||
| 4 | ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen | Antwerpen | Belgium | ||
| 5 | UZ Gasthuisberg Leuven | Leuven | Belgium | ||
| 6 | Centre Hospitalier Sud Amiens | Amiens cedex 1 | France | ||
| 7 | Hopital Femme Enfant Hématologie | Caen Cedex 9 | France | ||
| 8 | Hôpital d'instruction des armées Percy | Clamart | France | ||
| 9 | Centre hospitalier et universitaire (CHU) d´ Estaing | Clermont-Ferrand | France | ||
| 10 | Centre hospitalier et universitaire (CHU) de Limoges | Limoges cedex | France | ||
| 11 | Institut Paoli-Calmettes | Marseille cedex 9 | France | ||
| 12 | CHU de Nantes, Hôtel Dieu | Nantes cedex 01 | France | ||
| 13 | Centre Antoine Lacassagne | Nice cedex 2 | France | ||
| 14 | Centre hospitalier et universitaire (CHU) de Nice | Nice | France | ||
| 15 | Hopital Saint Antoine | Paris 12ème | France | ||
| 16 | CHU du Haut Lévêque | Pessac | France | ||
| 17 | Centre Hospitalier (CH) Saint Quentin | Saint Quentin cedex | France | ||
| 18 | University Aachen | Aachen | Germany | ||
| 19 | II. Medizinische Klinik, Hämatologie/Internistische Onkologie | Augsburg | Germany | ||
| 20 | Charité - Campus Benjamin Franklin | Berlin | Germany | ||
| 21 | Klinikum Chemnitz gGmbH | Chemnitz | Germany | ||
| 22 | Universitaetsklinikum Dresden | Dresden | Germany | ||
| 23 | Klinik für Innere Medizin C | Greifswald | Germany | ||
| 24 | University of Heidelberg | Heidelberg | Germany | ||
| 25 | Friedrich-Schiller-Universität Jena | Jena | Germany | ||
| 26 | University Hospital | Leipzig | Germany | 04103 | |
| 27 | Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität | Magdeburg | Germany | ||
| 28 | University of Münster | Münster | Germany | ||
| 29 | Klinikum Ernst von Bergmann gGmbH | Potsdam | Germany | ||
| 30 | University Regensburg | Regensburg | Germany | ||
| 31 | Universität Rostock | Rostock | Germany | ||
| 32 | Robert-Bosch-Krankenhaus | Stuttgart | Germany | ||
| 33 | Universität Tübingen | Tübingen | Germany | ||
| 34 | Allogeneic Stem Cell Transplant Cente | Würzburg | Germany | ||
| 35 | Academisch Ziekenhuis bij de Universiteit Amsterdam | Amsterdam | Netherlands | ||
| 36 | VU University Medical Center Amsterdam | Amsterdam | Netherlands | ||
| 37 | University Medical Centre Groningen | Groningen | Netherlands | ||
| 38 | University Hospital Maastricht | Maastricht | Netherlands | ||
| 39 | Erasmus MC-Daniel den Hoed Cancer Centre | Rotterdam | Netherlands | 3008 | |
| 40 | University Medical Centre Utrecht | Utrecht | Netherlands | ||
| 41 | Isala klinieken | Zwolle | Netherlands | ||
| 42 | Kantonsspital Aarau | Aarau | Switzerland | ||
| 43 | University Hospital | Basel | Switzerland | 4031 | |
| 44 | Inselspital Bern | Bern | Switzerland | ||
| 45 | Hopitaux Universitaires de Geneve | Geneve | Switzerland | 1211 | |
| 46 | CHUV Lausanne | Lausanne | Switzerland | ||
| 47 | Kantonsspital Luzern | Luzern 16 | Switzerland | ||
| 48 | University Hospital Zürich | Zürich | Switzerland |
Sponsors and Collaborators
- European Society for Blood and Marrow Transplantation
- 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
Investigators
- Study Chair: Dietger Niederwieser, Prof, EBMT and OSHO
- Study Chair: Bob Löwenberg, Prof, Stichting Hemato-Oncologie voor Volwassenen Nederland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2007-003514-34
- EBMT-ALWP01/2008