European Leukemia Trial Registry
Trial: HCT vs CT

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Public Title HCT Versus CT in Elderly AML
Scientific Title 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
Short Title HCT vs CT
Id KN/ELN LN_OSHO_2012_507
Trialgroup OSHO
Type of Trial multicentric, randomized, prospective, open-label, double-group
Phase Phase III
Disease Acute myeloid leukemia(AML) Stem cell transplantation
Stage of Disease .
Category stem cell transplantation
Elderly
Aim
  • Efficacy of allogeneic related or unrelated hematopoietic cell transplantation (HCT) after reduced intensity conditioning as a consolidation treatment for elderly patients with AML in complete remission.
  • Safety and toxicity of allogeneic related and unrelated HCT vs CT in elderly AML final 5.1, 2013-11-07 incl amendments 01-03 10 / 75 EBMT hematopoietic cell transplantation (HCT) after reduced intensity conditioning as a consolidation treatment for elderly patients with AML in complete remission.
Inclusion Criteria
  • Age >= 60 years 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 (i) The second study exclusively concerns induction therapy; (ii) Consolidation cycle one and two are given according to the accredited study group policy; (iii) No investigational drugs are used post registration for the HCT vs CT in eldery AML study; (iv) Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted
Age 60-75 years
Status Active
Start of Recruitment 01.10.2012
Recruiting Countries Germany
France
The Netherlands
Switzerland
Target Sample Size 231
Leader Niederwieser, Prof. Dr. med. Dr. h.c., Dietger
Contact Person

principal investigator
Niederwieser, Prof. Dr. med. Dr. h.c., Dietger
Tel: +49 (0)341 971 3050
Fax: +49 (0)341 971 3059
Email: dietger@medizin.uni-leipzig.de

Principal Investigator
Löwenberg, Prof. Dr. med, Bob
Tel: +31 (0)10 4087756
Fax: +31 (0)10 4089470
Email: b.lowenberg@erasmusmc.nl
Homepage: www1.erasmusmc.nl/hematologie/index.php

Shortprotocol Shortprotocol
Other Registers ClinicalTrials.gov NCT00766779
European Clinical Trials Database - EUDRACT 2007-003514-34
Outcomes
  • 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 (Primary Outcome)
  • To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT 5 Years
created 29.10.2012 Sina Hehn
changed 01.06.2015 Hanna Ebert
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