Trial Information
Assessment of Reduction of Cord Blood Transplantation Toxicity by Using Reduced Intensity Conditioning in Patients With Acute Myeloid Leukemia.
Individual meta-analysis is planned to compare geno-identical transplantation with
myeloid-ablative or non myeloid-ablative conditioning with UCBT after RIC.
Inclusion Criteria:
- Ages : 4 to 65
- De novo or secondary AML requiring allogeneic transplant
- No donor (related or unrelated) compatible 10/10
- Complete remission excepted CR1 with t(8;21) or inv (16) or t (15;17)
- Smouldering AML without progression
- Signed assent of recipient
Exclusion Criteria:
- If CR1: AML with with t(8;21) or inv (16) or t (15;17)
- Karnofsky < 50% - Clearance of creatinin < 40 ml/min
- Transaminases > 8 N
- Previous autologous or allogeneic transplantation within 6 month prior to the study
(except if tandem)
- total body irradiation contra-indicating 2 Gy TBI
- local irradiation contra-indicating 2 Gy TBI
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Transplant related mortality
Outcome Time Frame:
At 2 years
Safety Issue:
Yes
Principal Investigator
Bernard RIO, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistance Publique - Hôpitaux de Paris
Authority:
France: Ministry of Health
Study ID:
P 060206
NCT ID:
NCT00797758
Start Date:
October 2007
Completion Date:
December 2011
Related Keywords:
- Acute Myeloid Leukemia
- Cord blood transplantation
- Conditioning regimen
- Acute myeloid leukaemia
- SORROR comorbidity index
- Quality of life
- Innate immunity
- Immune reconstitution post transplant
- Umbilical Cord Blood Stem Cell Transplantation
- Hematopoietic Stem Cell Transplantation
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid