Phase I Trial of Pacritinib in Combination With Venetoclax and Azacitidine for the Treatment of Accelerated and Blast Phase Myeloproliferative Neoplasms
Roswell Park Cancer Institute
Summary
This phase I trial studies the side effects and best dose of pacritinib when given together with venetoclax and azacitidine in treating patients with accelerated and blast phase myeloproliferative neoplasms (MPN-AP/BP). Pacritinib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving pacritinib together with venetoclax and azacitidine may be safe, tolerable, and/or effective in treating patients with MPN-AP/BP
Description
PRIMARY OBJECTIVE: I. To estimate the maximum tolerated dose (MTD) of pacritinib when used in combination with venetoclax and azacitidine in subjects with MPN-AP/BP. SECONDARY OBJECTIVES: I. To evaluate the frequency and nature of adverse events of the combination of venetoclax, azacitidine, and pacritinib in subjects with accelerated and blast phase myeloproliferative neoplasms (MPN-AP/BP). II. To estimate the rate of responses as defined by European LeukemiaNet (ELN) 2022 response criteria for acute myeloid leukemia (AML). III. To estimate the rate of responses as defined by Post-Myelop…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 * Subjects must have accelerated phase MPN as defined by 10-19% blasts or blast phase MPN (AML) as defined by ≥ 20% blasts in the blood or bone marrow by manual aspirate differential, immunohistochemistry staining, or flow cytometry, with a documented prior diagnosis of essential thrombocythemia (ET), polycythemia vera (PV), or primary myelofibrosis (PMF), The absence of a spleen, lack of splenomegaly, or history of splenic irradiation is not exclusionary. * Subjects with blast phase MPN must be newly di…
Interventions
- DrugPacritinib
Subjects will be dosed until MTD is reached
- DrugVenetoclax
Given PO
- DrugAzacitidine
Given SC or IV
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureComputed Tomography
Undergo CT
- ProcedureBone Marrow Aspiration
Undergo bone marrrow aspiration
Location
- Roswell Park Comprehensive Cancer CenterBuffalo, New York