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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00797758
First Posted: November 25, 2008
Last Update Posted: March 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
November 24, 2008
November 25, 2008
March 8, 2013
October 2007
July 2011   (Final data collection date for primary outcome measure)
Transplant related mortality [ Time Frame: At 2 years ]
Same as current
Complete list of historical versions of study NCT00797758 on ClinicalTrials.gov Archive Site
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) [ Time Frame: at 2 years ]
Same as current
Not Provided
Not Provided
 
Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia
Assessment of Reduction of Cord Blood Transplantation Toxicity by Using Reduced Intensity Conditioning in Patients With Acute Myeloid Leukemia.
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.
Individual meta-analysis is planned to compare geno-identical transplantation with myeloid-ablative or non myeloid-ablative conditioning with UCBT after RIC.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myeloid Leukemia
Other: Cord blood transplantation
Umbilical cord blood transplantation after reduced intensity conditioning
Experimental: 1
Umbilical cord blood transplantation after reduced intensity conditioning
Intervention: Other: Cord blood transplantation
Rio B, Chevret S, Vigouroux S, Chevallier P, Fürst S, Sirvent A, Bay JO, Socié G, Ceballos P, Huynh A, Cornillon J, Françoise 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; Société Française de Greffe de Moelle et de Thérapie 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
December 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
4 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00797758
P 060206
Yes
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Bernard RIO, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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