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

Institut Paoli-Calmettes

Status and phase: Active, not recruiting; Phase 1

Conditions: Myelodysplastic Syndromes; Acute Myeloid Leukemia

Treatments: Biological: HLA-mismatched microtransplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03232268

MICROSTEM- IPC 2016-013

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

HLA-mismatched microtransplantation

Experimental group

Description:

HLA-mismatched microtransplantation without immunosuppressive treatment

Treatment:

Biological: HLA-mismatched microtransplantation