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

NCT ID: NCT00797758

Last Updated: 2013-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-12-31

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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Umbilical cord blood transplantation after reduced intensity conditioning

Group Type EXPERIMENTAL

Cord blood transplantation

Intervention Type OTHER

Umbilical cord blood transplantation after reduced intensity conditioning

Interventions

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Cord blood transplantation

Umbilical cord blood transplantation after reduced intensity conditioning

Intervention Type OTHER

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard RIO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Département d'Hématologie et d'Oncologie Médicale, Hôtel-Dieu

Paris, , France

Site Status

Countries

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France

References

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Rio B, Chevret S, Vigouroux S, Chevallier P, Furst S, Sirvent A, Bay JO, Socie G, Ceballos P, Huynh A, Cornillon J, Francoise S, Legrand F, Yakoub-Agha I, Michel G, Maillard N, Margueritte G, Maury S, Uzunov M, Bulabois CE, Michallet M, Clement L, Dauriac C, Bilger K, Gluckman E, Ruggeri A, Buzyn A, Nguyen S, Simon T, Milpied N, Rocha V; Societe Francaise de Greffe de Moelle et de Therapie Cellulaire and Eurocord. Decreased nonrelapse mortality after unrelated cord blood transplantation for acute myeloid leukemia using reduced-intensity conditioning: a prospective phase II multicenter trial. Biol Blood Marrow Transplant. 2015 Mar;21(3):445-53. doi: 10.1016/j.bbmt.2014.11.009. Epub 2014 Nov 18.

Reference Type DERIVED
PMID: 25460357 (View on PubMed)

Other Identifiers

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P 060206

Identifier Type: -

Identifier Source: org_study_id

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