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

Assessment of Reduction of Cord Blood Transplantation Toxicity by Using Reduced Intensity Conditioning in Patients With Acute Myeloid Leukemia.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00797758

Acronym

MINICORD

Enrollment

Registered

2008-11-25

Start date

2007-10-31

Completion date

2011-12-31

Last updated

2013-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERCord blood transplantation

Umbilical cord blood transplantation after reduced intensity conditioning

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Transplant related mortality	At 2 years

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026