Acute Myeloid Leukemia, Myelodysplastic Syndromes
Conditions
Keywords
Microtransplantation, Myeloid Hemopathy
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
Interventions
BIOLOGICALHLA-mismatched microtransplantation
3 administrations of hematopoietic stem cells without immunosupression
Sponsors
Institut Paoli-Calmettes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment | 100 days after transplantation | Cumulative incidence of acute GVH (grade 1 to 4) |
Countries
France
Outcome results
None listed