Acute Myeloid Leukemia Clinical Trial
A Study of BGB-11417 in Participants 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).
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.
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There are 23 Locations for this study
Houston Texas, 77030, United States
Benowa , 4217, Australia
Gold Coast , 4215, Australia
Heidelberg , 3084, Australia
Melbourne , 3004, Australia
Melbourne , 3065, Australia
Melbourne , 3168, Australia
Murdoch , 6150, Australia
Nedlands , 6009, Australia
Orange , 2800, Australia
Perth , 6009, Australia
Sydney , 2139, Australia
Sydney , 2217, Australia
Tugun , 4224, Australia
Beijing , 10004, China
Chengdu , 61004, China
Guangzhou , 51051, China
Nanchang , 33000, China
Wuhan , 43002, China
Auckland , 0620, New Zealand
Auckland , 2025, New Zealand
Wellington , 6021, New Zealand
Sevilla , 41013, Spain
Valencia , 46026, Spain
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