NCT00797758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

3.8 years

First QC Date

November 24, 2008

Last Update Submit

March 7, 2013

Conditions

Acute Myeloid Leukemia

Keywords

Cord blood transplantationConditioning regimenAcute myeloid leukaemiaSORROR comorbidity indexQuality of lifeInnate immunityImmune reconstitution post transplantUmbilical Cord Blood Stem Cell TransplantationHematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • Transplant related mortality

    At 2 years

Secondary Outcomes (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)

    at 2 years

Study Arms (1)

1

EXPERIMENTAL

Umbilical cord blood transplantation after reduced intensity conditioning

Other: Cord blood transplantation

Interventions

Cord blood transplantationOTHER

Umbilical cord blood transplantation after reduced intensity conditioning

1

Eligibility Criteria

Age4 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Paris, 75001, France

Location

Related Publications (1)

  • 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.

    PMID: 25460357DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cord Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Bernard RIO, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 25, 2008

Study Start

October 1, 2007

Primary Completion

July 1, 2011

Study Completion

December 1, 2011

Last Updated

March 8, 2013

Record last verified: 2013-03

Locations

FR(1)