A Study of BGB-11417 in Participants With Myeloid Malignancies
Acute Myeloid Leukemia
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) .
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
- AML, nonacute promyelocytic leukemia
- 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.
Key Exclusion Criteria:
- A diagnosis of acute promyelocytic leukemia.
- Prior malignancy within the past 2 years, except for curatively treated localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer.
- Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
- Prior therapy with a B-cell lymphoma-2 inhibitor or azacitidine except for participants who meet HMA-failure criteria
- Known central nervous system involvement by leukemia.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Dr. Carolyn Grove
Phase 1 & 2