Phase II Study of Cladribine, Cytarabine, Venetoclax, and Azacitidine for Higher-risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia

What this Trial Is About

Researchers are studying whether a combination of cladribine, cytarabine, venetoclax, and azacitidine can help control higher-risk myelodysplastic syndrome (MDS) with excess blasts and higher-risk chronic myelomonocytic leukemia (CMML). This phase II trial aims to assess the effectiveness, safety, and tolerability of these combined drugs in patients who have relapsed or are newly diagnosed with these conditions. The study also explores response rates, overall survival, and the potential for patients to proceed to stem-cell transplant. Participants receive treatment in cycles alternating between two drug combinations: cladribine, cytarabine, and venetoclax for two cycles, followed by azacitidine and venetoclax for two cycles. This alternating pattern repeats for up to a total of 18 cycles. Cladribine is given intravenously, cytarabine is given as a subcutaneous injection, venetoclax is taken orally, and azacitidine is administered either intravenously or subcutaneously. During the study, participants undergo regular assessments including monitoring for treatment responses based on specific criteria, evaluations of survival and relapse status, and genomic profiling to understand changes in disease mutations. Safety and tolerability are closely observed, with participants expected to remain in the study for about one year on average. The researchers also study how treatment impacts the disease at a molecular level and track the proportion of patients who become eligible for stem-cell transplantation.

A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts