Acute Myeloid Leukemia and Myelodysplastic Syndrome Clinical Trial
Official title:
Phase I Study of Single-agent and Combined Checkpoint Inhibition After Allogeneic Hematopoietic Stem Cell Transplantation in Patients at High Risk for Post-transplant Recurrence
The purpose of the study is to determine the safety and benefit of nivolumab, ipilimumab or the combination of nivolumab with ipilimumab given after bone marrow transplant for patients with acute myelogenous leukemia and myelodysplastic syndrome.
The primary objectives of this study are: - To assess the safety of single-agent and combined checkpoint inhibition with nivolumab and ipilimumab in patients with acute myelogenous leukemia and myelodysplastic syndrome who have undergone hematopoietic stem cell transplantation and are at high risk for post-transplant recurrence. - Safety endpoint: The composite endpoint consisting of the occurrence of at least one treatment-related limiting toxicity (after checkpoint inhibitor treatment is initiated) defined as a ≥ grade 4 non-hematologic toxicity as specified by the CTCAE. Exceptions listed in section 5.9 apply to this endpoint as well. If 3 of 7 patients in a single cohort experience a treatment-related limiting toxicity, that single cohort will be terminated. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05703204 -
A Study of QLF32101 in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
|
Phase 1 |