Phase 1Recruiting
Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation
A Phase I Study to Evaluate the Safety of Ruxolitinib in Combination With Azacitidine Maintenance in Patients Undergoing Reduced Intensity Allogeneic Transplant for Acute Myeloid Leukemia (AML)
- Sponsor
- OHSU Knight Cancer Institute (Academic or other)
- Enrolment
- 40 planned
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Allogeneic Hematopoietic Stem Cell Transplantation; Azacitidine; Biospecimen Collection; Bone Marrow Aspiration; Bone Marrow Biopsy; Cyclophosphamide; Echocardiography Test; Electronic Health Record Review; Multigated Acquisition Scan; Mycophenolate Mofetil; Reduced-Intensity Transplant Conditioning Procedure; Ruxolitinib
- Ages
- adults, older adults
- Registry
- NCT07548983
From the registry
This phase I trial studies the side effects and best dose of ruxolitinib (Rux) therapy alone (monotherapy) followed by Rux plus azacitidine (AZA) maintenance therapy and to see how well it works in treating patients with acute myeloid leukemia (AML) who are undergoing reduced intensity allogeneic hematopoietic stem cell transplantation (alloHSCT). AlloHSCT provides the only chance for cure for many patients with AML. AlloHSCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. This is often a sister or brother, but could be an unrelated donor. One of the common reasons for death after an alloHSCT is graft versus host disease (GVHD), which occurs when the transplanted cells from the donor attacks the recipient's normal cells. Ruxolitinib is in a class of medications called kinase inhibitors. It works to treat GVHD by blocking the signals of the cells that cause GVHD. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to…
Primary outcomes
- Incidence of dose limiting toxicities (DLTs)
- Incidence of grade 3+ treatment-related adverse events (TRAEs) (Part B)