Study of Mitoxantrone Liposomes, Cytarabine, G-CSF, and Venetoclax Treatment in Adults with Recurrent Acute Myeloid Leukemia and Myelodysplastic Syndrome with Increased Blast Cells

What this Trial Is About

Researchers are evaluating a combination treatment involving mitoxantrone hydrochloride liposomes, subcutaneous cytarabine, G-CSF, and Venetoclax CMGVen for adults with secondary acute myeloid leukemia AML or myelodysplastic syndrome with increased primordial cells type 2 MDS-IB2, as well as elderly AML patients. The study aims to assess the treatments effectiveness and safety in these recurrent or difficult-to-treat cases. Mitoxantrone is a chemotherapy drug that interferes with DNA and RNA, and this study explores a new liposomal form developed in China. The treatment includes an induction phase with mitoxantrone liposomes given intravenously, cytarabine injected subcutaneously twice daily for seven days, G-CSF injections starting one day before treatment, and oral Venetoclax given on days 4 to 10. Each treatment cycle lasts four weeks, with two cycles planned initially. Patients who respond well may receive an additional consolidation cycle or proceed to stem cell transplantation if eligible, while others continue consolidation therapy for several more cycles. Participants will undergo regular evaluations including clinical assessments, laboratory tests, and monitoring for side effects. The main outcome measured is the complete remission rate within one year. Additional outcomes monitored include overall response rate, survival, relapse-free survival, minimal residual disease levels, and adverse events over one to two years. The total study duration covers initial treatment, follow-up, and monitoring until the planned end date in 2027.

A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2/Elder AML