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

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

Official Title
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Assessment of Reduction of Cord Blood Transplantation Toxicity by Using Reduced Intensity Conditioning in Patients With Acute Myeloid Leukemia.

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Other: Cord blood transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Umbilical cord blood transplantation after reduced intensity conditioning | Other: Cord blood transplantation<br>* Umbilical cord blood transplantation after reduced intensity conditioning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant related mortality |  | At 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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