Clinical trial NCT00797758: Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia
Official title: Assessment of Reduction of Cord Blood Transplantation Toxicity by Using Reduced Intensity Conditioning in Patients With Acute Myeloid Leukemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: 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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 76
Sex: ALL
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Transplant related mortality
timeFrame: At 2 years
Secondary outcomes:
measure: 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)
timeFrame: at 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Département d'Hématologie et d'Oncologie Médicale, Hôtel-Dieu
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Bernard RIO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.