Trials / Terminated
TerminatedNCT04166929
Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS
Haploidentical Stem Cell Transplantation With or Without NK Cell Infusion in Refractory/Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndrome:The BigEMINy Study
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Haplo SCT with NK cells | Patients in this arm receive haplo-SCT followed by one boost of NK cells one/two weeks after the transplant. Lymphocyte are collected by apheresis from the donor one-two weeks after BM harvest. CD3 negative/CD56 positive cells are selected by immunomagnetic columns (other lymphocytes are stored to be used as DLI) |
| BIOLOGICAL | Haplo SCT | Patients in this arm receive a standard haplo-SCT. All administerd therapies are the same as in other arm, except for the NK cell boost.. |
Timeline
- Start date
- 2020-01-15
- Primary completion
- 2023-09-28
- Completion
- 2023-09-28
- First posted
- 2019-11-18
- Last updated
- 2023-10-04
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04166929. Inclusion in this directory is not an endorsement.