Phase 1b Study of Eganelisib Alone and With Cytarabine for Relapsed or Refractory Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes

What this Trial Is About

Researchers are evaluating eganelisib, both alone and combined with cytarabine, in patients with relapsed or refractory acute myeloid leukemia AML or higher-risk myelodysplastic syndromes HR-MDS. This Phase 1b open-label study aims to assess the safety, tolerability, how the body processes the drugs, and early anti-tumor effects. The study is divided into two parts dose escalation to find safe doses, and dose optimization for treatment refinement. Participants receive eganelisib either as a single drug or together with cytarabine. The study includes a dose escalation phase where doses are gradually increased and a dose optimization phase to fine-tune the treatment. Treatments are given under close medical supervision, and the study is open-label, so both doctors and patients know the treatments being given. During the trial, participants undergo regular assessments to monitor safety, side effects, and preliminary treatment effects according to established leukemia response criteria. Researchers will track adverse events, dose-limiting toxicities, and pharmacokinetic measures such as drug concentrations in the blood. Follow-up includes about one year of safety and activity monitoring. The total participation time varies depending on individual treatment and response.

Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML