Status:
TERMINATED
HCT Versus CT in Elderly AML
Lead Sponsor:
European Society for Blood and Marrow Transplantation
Collaborating Sponsors:
Acute Leukemia French Association
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60-75 years
Phase:
PHASE3
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 ...
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-remis...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00766779
Start Date
January 1 2010
End Date
December 1 2020
Last Update
October 14 2021
Active Locations (48)
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1
The Alfred Hospital
Melbourne Victoria, Australia
2
Hanusch Krankenhaus der Wiener Gebietskrankenkasse
Vienna, Austria
3
Medizinische Universität Wien
Vienna, Austria
4
ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen
Antwerp, Belgium