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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00797758
First received: November 24, 2008
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
 Other: Cord blood transplantation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Transplant related mortality [ Time Frame: At 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: October 2007
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Umbilical cord blood transplantation after reduced intensity conditioning
 Other: Cord blood transplantation
Umbilical cord blood transplantation after reduced intensity conditioning
Other Name: Cord blood transplantation

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

Ages Eligible for Study:   4 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00797758     History of Changes
Other Study ID Numbers: P 060206
Study First Received: November 24, 2008
Last Updated: March 7, 2013
Health Authority: France: Ministry of Health

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, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013