Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia (MINICORD)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

Other: Cord blood transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT00797758

P 060206

Details and patient eligibility

About

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 mortality and morbidity were limiting factors for the development of this procedure in adults. Non myeloablative conditioning regimen showed promising results and prospective evaluation has to be developed to confirm these retrospective data.

Full description

Individual meta-analysis is planned to compare geno-identical transplantation with myeloid-ablative or non myeloid-ablative conditioning with UCBT after RIC.

Enrollment

76 patients

Sex

All

Ages

4 to 65 years old

Volunteers

No Healthy Volunteers

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