NCT03232268

Brief Summary

This study aims at evaluating the safety of an approach based on HLA-mismatched Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies who are ineligible to conventional allograft

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2018

Longer than P75 for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

March 9, 2018

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

7.8 years

First QC Date

July 25, 2017

Last Update Submit

March 11, 2026

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndromes

Keywords

MicrotransplantationMyeloid Hemopathy

Outcome Measures

Primary Outcomes (1)

  • Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment

    Cumulative incidence of acute GVH (grade 1 to 4)

    100 days after transplantation

Study Arms (1)

HLA-mismatched microtransplantation

EXPERIMENTAL

HLA-mismatched microtransplantation without immunosuppressive treatment

Biological: HLA-mismatched microtransplantation

Interventions

HLA-mismatched microtransplantationBIOLOGICAL

3 administrations of hematopoietic stem cells without immunosupression

HLA-mismatched microtransplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\> or = 65 years with a myeloid hemopathy in Complete Remission or Complete remission with incomplete hematological recovery or Age\<65 years with an ineligibility to allograft (contraindication to conditioning)
  • HLA-partially matched family donors
  • Affiliated to(or beneficiary of) the Social Security
  • Informed consent signed

You may not qualify if:

  • AML3
  • Previous Hematopoietic Stem Cell TRansplantation
  • Uncontrolled infection -PS\>3 -Other progressive cancer
  • Psychiatric disease
  • Vulnerable person or unable to provide informed consent
  • Emergency
  • Unable to comply with required study follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, Bouches du Rhône, 13009, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2017

First Posted

July 27, 2017

Study Start

March 9, 2018

Primary Completion

January 7, 2026

Study Completion

January 7, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

FR(1)