Study Stopped
Recommendation of DMC
HCT Versus CT in Elderly AML
Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission
2 other identifiers
interventional
126
6 countries
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2010
Longer than P75 for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2008
CompletedFirst Posted
Study publicly available on registry
October 6, 2008
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedOctober 14, 2021
October 1, 2021
10.9 years
October 3, 2008
October 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT
5 Years
Study Arms (2)
Transplant Arm
EXPERIMENTALHematopoietic cell transplantation after Reduced Intensity Conditioning
Conventional Chemotherapy
ACTIVE COMPARATORThe non-transplant treatment approach for consolidation
Interventions
low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- European Society for Blood and Marrow Transplantationlead
- Acute Leukemia French Associationcollaborator
- Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasiascollaborator
- European Organisation for Research and Treatment of Cancer - EORTCcollaborator
- French Innovative Leukemia Organisationcollaborator
- HOVON - Dutch Haemato-Oncology Associationcollaborator
- East German Study Group of Hematology and Oncology (OSHO)collaborator
- Swiss Cancer Institutecollaborator
Study Sites (48)
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, 04103, 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, 3008, Netherlands
University Medical Centre Utrecht
Utrecht, Netherlands
Isala klinieken
Zwolle, Netherlands
Kantonsspital Aarau
Aarau, Switzerland
University Hospital
Basel, 4031, Switzerland
Inselspital Bern
Bern, Switzerland
Hopitaux Universitaires de Geneve
Geneva, 1211, Switzerland
CHUV Lausanne
Lausanne, Switzerland
Kantonsspital Luzern
Lucerne, Switzerland
University Hospital Zürich
Zurich, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dietger Niederwieser, Prof
EBMT and OSHO
- STUDY CHAIR
Bob Löwenberg, Prof
Stichting Hemato-Oncologie voor Volwassenen Nederland
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2008
First Posted
October 6, 2008
Study Start
January 1, 2010
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
October 14, 2021
Record last verified: 2021-10