Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS
- Conditions
- Acute Myeloid LeukemiaMyelodysplasia
- Registration Number
- NCT04166929
- Brief Summary
Relapse after an allogeneic hematopoietic stem cell transplantation (HSCT) is high in patients with advanced AML, in the 50% range. NK cells have been shown to possess significant anti-leukemic activity and may be used to reduce the incidence of relapse in patients with advanced AML.
Investigators hypothesize that the administration of a purified boost of NK cells on day +7 post HSCT, will reduce the incidence of relapse from the current 50% to 25%. In a phase III multicenter clinical study, 116 patients will be randomized to receive or not a boost of donor NK cells on day +7 post-HSCT. The first 10 patients in the experimental arm will be analyzed for toxicity. The stopping rule will be a transplant related mortality of more than 50% in the first 20 patients who received NK cells.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- Diagnosis of AML or MDS
- Patients not in remission at the time of transplant
- Age 18-75
- ECOG performance status <2
- Availability of a family HLA haploidentical donor, eligible to donate both marrow cells and unstimulated lymphocytes (1 apheresis procedure at day +7) .
- Positive serologic markers for human immunodeficiency virus (HIV)
- Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Leukemia relapse 1 year after bone marrow transplant Cumulative incidence of leukemia relapse.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fondazione Policlinico Universitario A. Gemelli IRCCS
🇮🇹Roma, RM, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS🇮🇹Roma, RM, Italy