Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
126 participants
INTERVENTIONAL
2010-01-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transplant Arm
Hematopoietic cell transplantation after Reduced Intensity Conditioning
hematopoietic cell transplantation
low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors
Conventional Chemotherapy
The non-transplant treatment approach for consolidation
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.
Interventions
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hematopoietic cell transplantation
low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
75 Years
ALL
No
Sponsors
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Acute Leukemia French Association
OTHER
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
French Innovative Leukemia Organisation
OTHER
HOVON - Dutch Haemato-Oncology Association
OTHER
East German Study Group of Hematology and Oncology (OSHO)
UNKNOWN
Swiss Cancer Institute
OTHER
European Society for Blood and Marrow Transplantation
NETWORK
Responsible Party
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Principal Investigators
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Dietger Niederwieser, Prof
Role: STUDY_CHAIR
EBMT and OSHO
Bob Löwenberg, Prof
Role: STUDY_CHAIR
Stichting Hemato-Oncologie voor Volwassenen Nederland
Locations
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The Alfred Hospital
Melbourne Victoria, , Australia
Hanusch Krankenhaus der Wiener Gebietskrankenkasse
Vienna, , Austria
Medizinische Universität Wien
Vienna, , Austria
ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen
Antwerp, , Belgium
UZ Gasthuisberg Leuven
Leuven, , Belgium
Centre Hospitalier Sud Amiens
Amiens, , France
Hopital Femme Enfant Hématologie
Caen, , France
Hôpital d'instruction des armées Percy
Clamart, , France
Centre hospitalier et universitaire (CHU) d´ Estaing
Clermont-Ferrand, , France
Centre hospitalier et universitaire (CHU) de Limoges
Limoges, , France
Institut Paoli-Calmettes
Marseille, , France
CHU de Nantes, Hôtel Dieu
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Centre hospitalier et universitaire (CHU) de Nice
Nice, , France
Hopital Saint Antoine
Paris 12ème, , France
CHU du Haut Lévêque
Pessac, , France
Centre Hospitalier (CH) Saint Quentin
Saint-Quentin, , France
University Aachen
Aachen, , Germany
II. Medizinische Klinik, Hämatologie/Internistische Onkologie
Augsburg, , Germany
Charité - Campus Benjamin Franklin
Berlin, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Universitaetsklinikum Dresden
Dresden, , Germany
Klinik für Innere Medizin C
Greifswald, , Germany
University of Heidelberg
Heidelberg, , Germany
Friedrich-Schiller-Universität Jena
Jena, , Germany
University Hospital
Leipzig, , Germany
Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität
Magdeburg, , Germany
University of Münster
Münster, , Germany
Klinikum Ernst von Bergmann gGmbH
Potsdam, , Germany
University Regensburg
Regensburg, , Germany
Universität Rostock
Rostock, , Germany
Robert-Bosch-Krankenhaus
Stuttgart, , Germany
Universität Tübingen
Tübingen, , Germany
Allogeneic Stem Cell Transplant Cente
Würzburg, , Germany
Academisch Ziekenhuis bij de Universiteit Amsterdam
Amsterdam, , Netherlands
VU University Medical Center Amsterdam
Amsterdam, , Netherlands
University Medical Centre Groningen
Groningen, , Netherlands
University Hospital Maastricht
Maastricht, , Netherlands
Erasmus MC-Daniel den Hoed Cancer Centre
Rotterdam, , Netherlands
University Medical Centre Utrecht
Utrecht, , Netherlands
Isala klinieken
Zwolle, , Netherlands
Kantonsspital Aarau
Aarau, , Switzerland
University Hospital
Basel, , Switzerland
Inselspital Bern
Bern, , Switzerland
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
CHUV Lausanne
Lausanne, , Switzerland
Kantonsspital Luzern
Lucerne, , Switzerland
University Hospital Zürich
Zurich, , Switzerland
Countries
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Other Identifiers
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EBMT-ALWP01/2008
Identifier Type: -
Identifier Source: secondary_id
2007-003514-34
Identifier Type: -
Identifier Source: org_study_id