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HCT Versus CT in Elderly AML
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
hematopoietic cell transplantation, Acute Myeloid Leukemia, first Complete Remission
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: hematopoietic cell transplantation
Type: Procedure
Name: Non-Transplant treatment approach for consolidation
Type: Drug
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 60 Years
Gender: Both
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
- 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
Locations
The Alfred Hospital
Melbourne Victoria, Australia
Hanusch Krankenhaus der Wiener Gebietskrankenkasse
Status: Recruiting
Wien, Austria
Medizinische Universität Wien
Status: Not yet recruiting
Wien, Austria
ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen
Status: Recruiting
Antwerpen, Belgium
UZ Gasthuisberg Leuven
Status: Not yet recruiting
Leuven, Belgium
Centre Hospitalier Sud Amiens
Status: Not yet recruiting
Amiens cedex 1, France
Centre hospitalier et universitaire (CHU) d´Angers
Status: Recruiting
Angers, France
Centre hospitalier Victor Dupouy
Status: Not yet recruiting
Argenteuil, France
Hôpital Jean Minjoz
Status: Not yet recruiting
Besançon cedex, France
Centre hospitalier et universitaire (CHU) de Brest, Hôpital Morvan
Status: Not yet recruiting
Brest cedex, France
Hopital Femme Enfant Hématologie
Status: Not yet recruiting
Caen Cedex 9, France
Hôpital d'instruction des armées Percy
Status: Recruiting
Clamart, France
Centre hospitalier et universitaire (CHU) d´ Estaing
Status: Not yet recruiting
Clermont-Ferrand, France
Centre Hospitalier Sud Francilien
Status: Recruiting
Corbeil essonnes cedex, France
Hopital Henri Mondor
Status: Not yet recruiting
CRETEIL Cedex, France
Hopital d'enfants
Status: Not yet recruiting
Dijon, France
Centre Hospitalier de VERSAILLES
Status: Not yet recruiting
Le Chesnay cedex, France
Centre hospitalier et universitaire (CHU) de Limoges
Status: Not yet recruiting
Limoges cedex, France
Institut Paoli-Calmettes
Status: Not yet recruiting
Marseille cedex 9, France
CHU de Nantes, Hôtel Dieu
Status: Not yet recruiting
Nantes cedex 01, France
Centre Antoine Lacassagne
Status: Recruiting
Nice cedex 2, France
Centre hospitalier et universitaire (CHU) de Nice
Status: Recruiting
Nice, France
Hopital Saint Antoine
Status: Recruiting
PARIS 12ème, France
Hopital Saint Louis
Status: Recruiting
Paris cedex 10, France
Hopital Necker
Status: Not yet recruiting
Paris cedex 15, France
CHU du Haut Lévêque
Status: Not yet recruiting
Pessac, France
Hôpital de Pontchaillou
Status: Recruiting
Rennes, France
Centre Hospitalier (CH) Saint Quentin
Status: Not yet recruiting
Saint Quentin cedex, France
Hôpital Hautepierre
Status: Recruiting
Strasbourg cedex, France
University Aachen
Status: Not yet recruiting
Aachen, Germany
II. Medizinische Klinik, Hämatologie/Internistische Onkologie
Status: Recruiting
Augsburg, Germany
Charité - Campus Benjamin Franklin
Status: Not yet recruiting
Berlin, Germany
Klinikum Chemnitz gGmbH
Status: Recruiting
Chemnitz, Germany
Universitaetsklinikum Dresden
Status: Recruiting
Dresden, Germany
Klinik für Innere Medizin C
Status: Recruiting
Contact: Johannes Schetelig, PD Dr. med.
Greifswald, Germany
University of Heidelberg
Status: Recruiting
Heidelberg, Germany
Friedrich-Schiller-Universität Jena
Status: Recruiting
Jena, Germany
University Hospital
Status: Recruiting
Leipzig, Germany
Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität
Status: Recruiting
Contact: Dietger Niederwieser - dietger@medizin.uni-leipzig.de
Magdeburg, Germany
University of Münster
Status: Recruiting
Münster, Germany
Klinikum Ernst von Bergmann gGmbH
Status: Recruiting
Potsdam, Germany
University Regensburg
Status: Recruiting
Regensburg, Germany
Universität Rostock
Status: Recruiting
Rostock, Germany
Robert-Bosch-Krankenhaus
Status: Recruiting
Stuttgart, Germany
Universität Tübingen
Status: Recruiting
Tübingen, Germany
Allogeneic Stem Cell Transplant Cente
Status: Recruiting
Würzburg, Germany
Academisch Ziekenhuis bij de Universiteit Amsterdam
Status: Recruiting
Amsterdam, Netherlands
VU University Medical Center Amsterdam
Status: Recruiting
Amsterdam, Netherlands
University Medical Centre Groningen
Status: Recruiting
Groningen, Netherlands
University Hospital Maastricht
Status: Not yet recruiting
Contact: G Huls, Dr. - g.huls@int.umcg.nl
Maastricht, Netherlands
Erasmus MC-Daniel den Hoed Cancer Centre
Status: Recruiting
Contact: H. Schouten, Prof. Dr
Rotterdam, Netherlands
University Medical Centre Utrecht
Status: Recruiting
Contact: Bob Löwenberg - b.lowenberg@erasmusmc.nl
Utrecht, Netherlands
Isala klinieken
Status: Recruiting
Zwolle, Netherlands
Kantonsspital Aarau
Status: Recruiting
Aarau, Switzerland
University Hospital
Status: Not yet recruiting
Basel, Switzerland
Inselspital Bern
Status: Recruiting
Contact: Dominik Heim, PD Dr. - hematology@uhbs.ch
Bern, Switzerland
Hopitaux Universitaires de Geneve
Status: Not yet recruiting
Geneve, Switzerland
CHUV Lausanne
Status: Recruiting
Contact: Yves Chalandon - yves.chalandon@hcuge.ch
Lausanne, Switzerland
Kantonsspital Luzern
Status: Not yet recruiting
Luzern 16, Switzerland
University Hospital Zürich
Status: Not yet recruiting
Zürich, Switzerland
Status: Recruiting
Start Date
January 2010
Completion Date
December 2018
Sponsors
Clinical Trials
Source
European Group for Blood and Marrow Transplantation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page