HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies

Phase 1

Active, not recruiting

• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes
• Interventions: Biological: HLA-mismatched microtransplantation

• Registration Number: NCT03232268
• Lead Sponsor: Institut Paoli-Calmettes

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-27
• Study Start: 2018-03-09
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-15
• Primary Completion: 2027-03-09
• Study Completion: 2027-03-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HLA-mismatched microtransplantation	HLA-mismatched microtransplantation	HLA-mismatched microtransplantation without immunosuppressive treatment

Primary Outcome Measures

Name	Time	Method
Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment	100 days after transplantation	Cumulative incidence of acute GVH (grade 1 to 4)

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, Bouches du Rhône, France