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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Cord blood transplantation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring 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

Eligibility Criteria

4 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Département d'Hématologie et d'Oncologie Médicale, Hôtel-Dieu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Umbilical cord blood transplantation after reduced intensity conditioning

Outcomes

Primary Outcome Measures

Transplant related mortality

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)

Full Information

First Posted
November 24, 2008
Last Updated
March 7, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00797758
Brief Title
Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia
Acronym
MINICORD
Official Title
Assessment of Reduction of Cord Blood Transplantation Toxicity by Using Reduced Intensity Conditioning in Patients With Acute Myeloid Leukemia.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Individual meta-analysis is planned to compare geno-identical transplantation with myeloid-ablative or non myeloid-ablative conditioning with UCBT after RIC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Umbilical cord blood transplantation after reduced intensity conditioning
Intervention Type
Other
Intervention Name(s)
Cord blood transplantation
Intervention Description
Umbilical cord blood transplantation after reduced intensity conditioning
Primary Outcome Measure Information:
Title
Transplant related mortality
Time Frame
At 2 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard RIO, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Département d'Hématologie et d'Oncologie Médicale, Hôtel-Dieu
City
Paris
ZIP/Postal Code
75001
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25460357
Citation
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.
Results Reference
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Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia

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