Study of Oral BGB-11417 Alone and with Azacitidine for Treating Acute Myeloid Leukemia and Myelodysplastic Syndromes

What this Trial Is About

Researchers are evaluating the safety, tolerability, recommended Phase 2 dose, and preliminary effectiveness of BGB-11417 alone and combined with azacitidine in adults with acute myeloid leukemia AML, myelodysplastic syndrome MDS, or MDSmyeloproliferative neoplasm MPN. The study includes participants with these myeloid cancers to better understand treatment responses and potential drug interactions. Participants receive BGB-11417 orally on a 28-day cycle, with dosing schedules varying between 10, 14, 21, or 28 days, depending on the cohort. Azacitidine is given intravenously or subcutaneously for 7 days in combination with BGB-11417 for certain groups. A subset of participants with AML and MDS also receive a modified second cycle to explore interactions with posaconazole, which is given orally for 8 days during this cycle. Some participants with MDS and relapsedrefractory AML in China receive BGB-11417 monotherapy. Throughout the study, participants are monitored for dose-limiting toxicities, adverse events, and response rates including remission and hematologic improvements over approximately 24 months. Blood samples are collected to measure drug levels and interactions during specific cycles. Participants health and responses are assessed regularly to evaluate safety and preliminary efficacy, with follow-up continuing until study completion or withdrawal.

A Study of BGB-11417 in Participants With Myeloid Malignancies