Study of Combined Cladribine, Idarubicin, Cytarabine, and Oral Quizartinib for Adults with New or Returning Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

What this Trial Is About

Researchers are evaluating the side effects and effectiveness of a combination of drugscladribine, idarubicin, cytarabine, and quizartinibin treating adults with acute myeloid leukemia AML or high-risk myelodysplastic syndrome MDS that is newly diagnosed, has returned, or does not respond to prior treatment. These chemotherapy drugs work in different ways to stop cancer cell growth, and quizartinib may block enzymes needed for cell growth. The study aims to assess safety, overall survival, disease-free survival, and genetic factors related to treatment response. Participants receive induction treatment with idarubicin, cladribine, and cytarabine intravenously over several days, followed by oral quizartinib daily for two weeks. This induction cycle can repeat up to two times if the disease does not progress or toxicity is acceptable. Those who respond continue with consolidation treatment involving similar drugs over shorter periods, with quizartinib given daily for up to 5 cycles. Patients achieving further response enter maintenance, receiving quizartinib daily for up to 12 cycles. After completing treatment, participants are followed every 6 to 12 months. During the study, participants undergo regular drug administrations and clinical evaluations to monitor treatment effects and side effects. Researchers measure event-free survival and adverse events for up to 12 months, along with overall survival, disease-free survival, response rates, and changes in specific gene mutations and FLT3 ligand levels. Advanced laboratory tests like CyTOF and single-cell sequencing are used to study treatment-resistant cells. Safety monitoring and follow-up continue beyond active treatment to assess long-term outcomes.

Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome