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

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Other: Cord blood transplantation

• 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Primary Completion: 2011-07
• Study Completion: 2011-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Cord blood transplantation	Umbilical cord blood transplantation after reduced intensity conditioning

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