Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia
Phase 2
Completed
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NCT00797758
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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 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.
- Detailed Description
Individual meta-analysis is planned to compare geno-identical transplantation with myeloid-ablative or non myeloid-ablative conditioning with UCBT after RIC.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Transplant related mortality At 2 years
- Secondary Outcome Measures
Name Time Method Clinical efficiency (overall survival, event free survival, relapse incidence, acute and chronic GVHD incidence, graft failure, venoocclusive disease, interstitial pneumonia, infections, comorbidity score, quality of life and medico-economic impact) at 2 years
Trial Locations
- Locations (1)
Département d'Hématologie et d'Oncologie Médicale, Hôtel-Dieu
🇫🇷Paris, France
Département d'Hématologie et d'Oncologie Médicale, Hôtel-Dieu🇫🇷Paris, France