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

Phase 1Active Not RecruitingNCT03232268

Institut Paoli-Calmettes25 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndromes

Interventions

HLA-mismatched microtransplantationBIOLOGICAL

3 administrations of hematopoietic stem cells without immunosupression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Paoli Calmettes

Marseille, Bouches du Rhône, France

Outcomes

Primary Outcomes

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)

Time frame: 100 days after transplantation

Data from ClinicalTrials.gov

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