Tests BGB-11417 alone or with azacitidine in myeloid blood cancers
Tests BGB-11417, alone or with azacitidine, in adults with acute myeloid leukemia or MDS.
Plain-language title generated from the registry record
Registry title: A Study of BGB-11417 in Participants With Myeloid Malignancies
Key facts
- Where
- Bologna, Meldola, and Milan, ItalySee the 3 sites
- Phase
- Phase 1/2
Where in Italy
- Azienda Unita Sanitaria Locale Di BolognaBologna, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BeOne Medicines
- Trial code
- NCT04771130EU 2023-508881-14-00
- Record updated
- 14 September 2026
- Original description
The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .Read full original descriptionShow less
A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies
The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .
Inclusion: Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:; AML, nonacute promyelocytic leukemia; MDS; MDS/MPN; Eastern Cooperative Oncology Group performance status of 0 to 2; Adequate organ function defined as:; Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort); Adequate liver function; Life expectancy of > 12 weeks; Ability to comply with the requirements of the study.
Exclusion: Prior therapy with a B-cell lymphoma-2 inhibitor; History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer); A diagnosis of acute promyelocytic leukemia; Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation; Known central nervous system involvement by leukemia; Note: Other protocol defined Inclusion/Exclusion criteria may apply.