Acute Myeloid Leukemia Clinical Trial
— MICROSTEMOfficial title:
HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies
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
| Status | Recruiting |
| Enrollment | 32 |
| Est. completion date | March 8, 2025 |
| Est. primary completion date | March 8, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Institut Paoli Calmettes | Marseille | Bouches Du Rhône |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Paoli-Calmettes |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | 100 days after transplantation |
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