Status:
COMPLETED
Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
4-65 years
Phase:
PHASE2
Brief Summary
Multicentric evaluation of the reduction of unrelated cord blood transplantation (UCBT) toxicity by using reduced intensity conditioning (RIC) in patients with acute myeloid leukaemia.UCBT related mor...
Detailed Description
Individual meta-analysis is planned to compare geno-identical transplantation with myeloid-ablative or non myeloid-ablative conditioning with UCBT after RIC.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00797758
Start Date
October 1 2007
End Date
December 1 2011
Last Update
March 8 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Département d'Hématologie et d'Oncologie Médicale, Hôtel-Dieu
Paris, France, 75001