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
60 Years
75 Years
Both
Acute Myeloid Leukemia
Trial Information
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
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Dietger Niederwieser, Prof
Investigator Role:
Study Chair
Investigator Affiliation:
EBMT and OSHO
Authority:
Belgium: Federal Agency for Medicinal Products and Health Products
Study ID:
2007-003514-34
NCT ID:
NCT00766779
Start Date:
January 2010
Completion Date:
December 2017
Related Keywords:
- Acute Myeloid Leukemia
- hematopoietic cell transplantation
- Acute Myeloid Leukemia
- first Complete Remission
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|
