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)
OHSU Knight Cancer Institute
Summary
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 produce normal blood cells and by killing abnormal cells in the bone marrow. Giving Rux after the transplant may stop GVHD from occurring. Maintenance therapy with AZA, may help prevent or delay cancer from coming back. Giving Rux monotherapy followed by Rux plus AZA maintenance therapy may be safe, tolerable, and/or effective in treating patients with AML who are undergoing alloHSCT.
Description
PRIMARY OBJECTIVE: I. To determine the safety and tolerability of Rux monotherapy (part A) and Rux plus AZA therapy (part B) following alloHSCT in AML patients. SECONDARY OBJECTIVES: I. To determine the feasibility of Rux plus AZA maintenance. II. To determine the effect on measurable residual disease (MRD) of Rux plus AZA maintenance. III. To determine the impact on neutrophil engraftment of study treatment. IV. To determine the impact on platelet engraftment of study treatment. V. To determine the frequency and timing of disease relapse after alloHSCT when treated with Rux plus AZA maint…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * PART A: Willingness to provide written informed consent before any study-specific procedures or interventions are performed. For participants unable to independently provide consent, a legally authorized representative (LAR) must provide consent * PART A: Age ≥ 18 years, at the time of consent * PART A: All types and categories of AML, as defined by World Health Organization (WHO) 2022, excluding acute promyelocytic leukemia (APL) * PART A: In complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after induction of remission for transit…
Interventions
- ProcedureAllogeneic Hematopoietic Stem Cell Transplantation
Undergo alloHSCT
- DrugAzacitidine
Given IV
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- DrugCyclophosphamide
Given IV
- ProcedureEchocardiography Test
Location
- OHSU Knight Cancer InstitutePortland, Oregon