Haploidentical Donor Hematopoietic Progenitor Cell and NK Cell Transplantation for Hematologic Malignancy
Status:
Completed
Trial end date:
2021-09-27
Target enrollment:
Participant gender:
Summary
In this study, participants with high-risk hematologic malignancies undergoing hematopoietic
cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA) matched
related/sibling donor (MSD) or matched unrelated donor (MUD) identified, will receive a
haploidentical donor HCT with additional natural killer (NK) cells.
The investigators anticipate enrollment of 75 donors and 75 recipients.
PRIMARY OBJECTIVE:
- To estimate the rate of successful engraftment at day +42 post-transplant in patients
who receive haploidentical donor stem cell plus NK cell transplantation with TLI based
conditioning regimen for high risk hematologic malignancy.
SECONDARY OBJECTIVES:
- Estimate the incidence of malignant relapse, event-free survival, and overall survival
at one-year post-transplantation.
- Estimate incidence and severity of acute and chronic (GVHD).
- Estimate the rate of transplant related mortality (TRM) in the first 100 days after
transplantation.