NCT03439371

Brief Summary

This study aims at evaluating the safety and the tolerance of the micro-transplantation in elderly patients with acute myeloid leukemia who are ineligible to conventional allogeneic transplantation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

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 Progress82%
Jan 2019Dec 2027

First Submitted

Initial submission to the registry

February 5, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

January 8, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

7 years

First QC Date

February 5, 2018

Last Update Submit

April 7, 2025

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid LeukemiaMicro-transplantationElderlyGraft-versus-leukemia

Outcome Measures

Primary Outcomes (1)

  • Rate of overall survival

    Rate of overall survival will be reported.

    2 years

Secondary Outcomes (8)

  • Hematopoietic recovery

    3 months

  • Hematopoietic recovery

    3 months

  • Hematopoietic recovery

    3 months

  • Rate of complete remission

    2 years

  • GVHD (graft versus host disease)

    2 years

  • +3 more secondary outcomes

Study Arms (1)

HLA-mismatched micro-transplantation

EXPERIMENTAL

HLA-mismatched micro-transplantation

Other: HLA-mismatched micro-transplantation after induction chemotherapy

Interventions

HLA-mismatched micro-transplantation after induction chemotherapyOTHER

HLA-mismatched micro-transplantation after induction chemotherapy

HLA-mismatched micro-transplantation

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient affiliated to a social security regimen or beneficiary of the same
  • Signed written informed consent form
  • Patient, ≥ 60 years-old - \< 75 years-old, with established diagnosis of de novo or secondary AML with intermediate-risk or adverse-risk cytogenetic profile, or with established myelodysplasic syndromes (RAEB), in pathologically confirmed complete remission following anti-leukemic induction therapy (\<5% blasts)
  • Contra-indication to conditioning regimen in conventional allogeneic transplantation

You may not qualify if:

  • Patient with established diagnosis of acute myeloid leukemia with standard-risk cytogenetic profile
  • Promyelocytic leukemia t(15;17)
  • CBF-AML t(8;21) or inv(16)
  • Normal karyotype with a favorable molecular profile: NPM1+ and FLT3-; NPM1+, FLT3- and double mutation CEBPα or chronic myeloid leukemia in blastic phase
  • Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
  • Refusing participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU Estaing

Clermont-Ferrand, 63000, France

RECRUITING

Centre Hospitalier Universitaire de Grenoble

Grenoble, France

RECRUITING

CHRU de Lille

Lille, France

NOT YET RECRUITING

Centre Hospitalier Lyon Sud

Lyon, France

RECRUITING

Centre Hospitalier Universitaire de Nancy

Nancy, France

NOT YET RECRUITING

Hôpital de la Pitié-Salpêtrière

Paris, France

NOT YET RECRUITING

CHU de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jérôme Cornillon, MD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérôme Cornillon, MD

CONTACT

04 77 91 67 26jerome.cornillon@chu-st-etienne.fr

Elisabeth Daguenet, PhD

CONTACT

04 77 91 70 89elisabeth.daguenet@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 20, 2018

Study Start

January 8, 2019

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)