NCT03232268CompletedPhase 1
HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies
Institut Paoli-Calmettes1 site in 1 country25 target enrollmentStarted: March 9, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
HLA-mismatched microtransplantation
Experimental
HLA-mismatched microtransplantation without immunosuppressive treatment
Intervention: HLA-mismatched microtransplantation (Biological)
Outcomes
Primary Outcomes
Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment
Time Frame: 100 days after transplantation
Cumulative incidence of acute GVH (grade 1 to 4)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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