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
Locations
The Alfred Hospital
Melbourne Victoria, Australia
Status: Recruiting
Hanusch Krankenhaus der Wiener Gebietskrankenkasse
Wien, Austria
Status: Not yet recruiting
Medizinische Universität Wien
Wien, Austria
Status: Recruiting
ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen
Antwerpen, Belgium
Status: Not yet recruiting
UZ Gasthuisberg Leuven
Leuven, Belgium
Status: Not yet recruiting
Centre Hospitalier Sud Amiens
Amiens cedex 1, France
Status: Recruiting
Centre hospitalier et universitaire (CHU) d´Angers
Angers, France
Status: Not yet recruiting
Centre hospitalier Victor Dupouy
Argenteuil, France
Status: Not yet recruiting
Hôpital Jean Minjoz
Besançon cedex, France
Status: Not yet recruiting
Centre hospitalier et universitaire (CHU) de Brest, Hôpital Morvan
Brest cedex, France
Status: Not yet recruiting
Hopital Femme Enfant Hématologie
Caen Cedex 9, France
Status: Recruiting
Hôpital d'instruction des armées Percy
Clamart, France
Status: Not yet recruiting
Centre hospitalier et universitaire (CHU) d´ Estaing
Clermont-Ferrand, France
Status: Recruiting
Centre Hospitalier Sud Francilien
Corbeil essonnes cedex, France
Status: Not yet recruiting
Hopital Henri Mondor
CRETEIL Cedex, France
Status: Not yet recruiting
Hopital d'enfants
Dijon, France
Status: Not yet recruiting
Centre Hospitalier de VERSAILLES
Le Chesnay cedex, France
Status: Not yet recruiting
Centre hospitalier et universitaire (CHU) de Limoges
Limoges cedex, France
Status: Not yet recruiting
Institut Paoli-Calmettes
Marseille cedex 9, France
Status: Not yet recruiting
CHU de Nantes, Hôtel Dieu
Nantes cedex 01, France
Status: Recruiting
Centre Antoine Lacassagne
Nice cedex 2, France
Status: Recruiting
Centre hospitalier et universitaire (CHU) de Nice
Nice, France
Status: Recruiting
Hopital Saint Antoine
PARIS 12ème, France
Status: Recruiting
Hopital Saint Louis
Paris cedex 10, France
Status: Not yet recruiting
Hopital Necker
Paris cedex 15, France
Status: Not yet recruiting
CHU du Haut Lévêque
Pessac, France
Status: Recruiting
Hôpital de Pontchaillou
Rennes, France
Status: Not yet recruiting
Centre Hospitalier (CH) Saint Quentin
Saint Quentin cedex, France
Status: Recruiting
Hôpital Hautepierre
Strasbourg cedex, France
Status: Not yet recruiting
University Aachen
Aachen, Germany
Status: Recruiting
II. Medizinische Klinik, Hämatologie/Internistische Onkologie
Augsburg, Germany
Status: Not yet recruiting
Charité - Campus Benjamin Franklin
Berlin, Germany
Status: Recruiting
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Status: Recruiting
Universitaetsklinikum Dresden
Dresden, Germany
Status: Recruiting
Contact: Johannes Schetelig, PD Dr. med.
Klinik für Innere Medizin C
Greifswald, Germany
Status: Recruiting
University of Heidelberg
Heidelberg, Germany
Status: Recruiting
Friedrich-Schiller-Universität Jena
Jena, Germany
Status: Recruiting
University Hospital
Leipzig, Germany
Status: Recruiting
Contact: Dietger Niederwieser - dietger@medizin.uni-leipzig.de
Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität
Magdeburg, Germany
Status: Recruiting
University of Münster
Münster, Germany
Status: Recruiting
Klinikum Ernst von Bergmann gGmbH
Potsdam, Germany
Status: Recruiting
University Regensburg
Regensburg, Germany
Status: Recruiting
Universität Rostock
Rostock, Germany
Status: Recruiting
Robert-Bosch-Krankenhaus
Stuttgart, Germany
Status: Recruiting
Universität Tübingen
Tübingen, Germany
Status: Recruiting
Allogeneic Stem Cell Transplant Cente
Würzburg, Germany
Status: Recruiting
Academisch Ziekenhuis bij de Universiteit Amsterdam
Amsterdam, Netherlands
Status: Recruiting
VU University Medical Center Amsterdam
Amsterdam, Netherlands
Status: Recruiting
University Medical Centre Groningen
Groningen, Netherlands
Status: Not yet recruiting
Contact: G Huls, Dr. - g.huls@int.umcg.nl
University Hospital Maastricht
Maastricht, Netherlands
Status: Recruiting
Contact: H. Schouten, Prof. Dr
Erasmus MC-Daniel den Hoed Cancer Centre
Rotterdam, Netherlands
Status: Recruiting
Contact: Bob Löwenberg - b.lowenberg@erasmusmc.nl
University Medical Centre Utrecht
Utrecht, Netherlands
Status: Recruiting
Isala klinieken
Zwolle, Netherlands
Status: Recruiting
Kantonsspital Aarau
Aarau, Switzerland
Status: Not yet recruiting
University Hospital
Basel, Switzerland
Status: Recruiting
Contact: Dominik Heim, PD Dr. - hematology@uhbs.ch
Inselspital Bern
Bern, Switzerland
Status: Not yet recruiting
Hopitaux Universitaires de Geneve
Geneve, Switzerland
Status: Recruiting
Contact: Yves Chalandon - yves.chalandon@hcuge.ch
CHUV Lausanne
Lausanne, Switzerland
Status: Not yet recruiting
Kantonsspital Luzern
Luzern 16, Switzerland
Status: Not yet recruiting
University Hospital Zürich
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