Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia
NCT ID: NCT00797758
Last Updated: 2013-03-08
Study Results
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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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2007-10-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Umbilical cord blood transplantation after reduced intensity conditioning
Cord blood transplantation
Umbilical cord blood transplantation after reduced intensity conditioning
Interventions
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Cord blood transplantation
Umbilical cord blood transplantation after reduced intensity conditioning
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
4 Years
65 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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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
Countries
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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.
Other Identifiers
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P 060206
Identifier Type: -
Identifier Source: org_study_id
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