We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  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
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.

Resource links provided by NLM:


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

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

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 ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: November 24, 2008
First Posted: November 25, 2008
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