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

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ClinicalTrials.gov Identifier: NCT00797758
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Other: Cord blood transplantation Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Reduction of Cord Blood Transplantation Toxicity by Using Reduced Intensity Conditioning in Patients With Acute Myeloid Leukemia.
Study Start Date : October 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2011


Arm Intervention/treatment
Experimental: 1
Umbilical cord blood transplantation after reduced intensity conditioning
Other: Cord blood transplantation
Umbilical cord blood transplantation after reduced intensity conditioning



Primary Outcome Measures :
  1. Transplant related mortality [ Time Frame: At 2 years ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   4 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797758


Locations
France
Département d'Hématologie et d'Oncologie Médicale, Hôtel-Dieu
Paris, France, 75001
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Bernard RIO, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00797758     History of Changes
Other Study ID Numbers: P 060206
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: March 8, 2013
Last Verified: March 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms