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

NCT ID: NCT03232268

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-09

Study Completion Date

2027-03-09

Brief Summary

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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

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Conditions

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Acute Myeloid Leukemia Myelodysplastic Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HLA-mismatched microtransplantation

HLA-mismatched microtransplantation without immunosuppressive treatment

Group Type EXPERIMENTAL

HLA-mismatched microtransplantation

Intervention Type BIOLOGICAL

3 administrations of hematopoietic stem cells without immunosupression

Interventions

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HLA-mismatched microtransplantation

3 administrations of hematopoietic stem cells without immunosupression

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Paoli Calmettes

Marseille, Bouches du Rhône, France

Site Status

Countries

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France

Other Identifiers

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MICROSTEM- IPC 2016-013

Identifier Type: -

Identifier Source: org_study_id

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