Adoptive Transfer of Haplo-identical DLI for AML and MDS
Status:
Completed
Trial end date:
2019-07-31
Target enrollment:
Participant gender:
Summary
The primary hypothesis is that chemotherapy followed by donor lymphocyte infusion (DLI) from
HLA-haploidentical donors is a safe procedure that will not cause Graft versus Host Disease
(GVHD) or increased treatment-related mortality. The Investigator further believes that this
will improve outcomes of elderly patients with high-risk AML or MDS compared to chemotherapy
alone, and that that this benefit will be even greater in donor-recipient pairs that share
maternal-fetal microchimerism or non-inherited maternal antigen (NIMA) mismatch. A large part
of this trial will include immune function assays as well as assessments of efficacy,
toxicity, and GVHD. Because this therapy may be a tolerable alternative to allogeneic
hematopoietic stem cell transplantation (alloHSCT) for elderly patients, the Investigator
will validate functional measurements (e.g. Comprehensive Geriatric Assessment (CGA)) with
biologic correlates (cytokine and genomic profiles) and clinical outcomes.