Acute Myeloid Leukemia Clinical Trial
A Study of BGB-11417 in Participants With Myeloid Malignancies
Summary
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).
Eligibility Criteria
Key Inclusion Criteria:
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.
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 40 Locations for this study
Duarte California, 91010, United States
Tampa Florida, 33606, United States
Columbia Maryland, 21044, United States
Pittsburgh Pennsylvania, 15232, United States
Houston Texas, 77030, United States
Milwaukee Wisconsin, 53226, United States
Concord New South Wales, 2139, Australia
Kogarah New South Wales, 2217, Australia
Orange New South Wales, 2800, Australia
Southport Queensland, 4215, Australia
Tugun Queensland, 4224, Australia
Clayton Victoria, 3168, Australia
Fitzroy Victoria, 3065, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3004, Australia
Murdoch Western Australia, 6150, Australia
Nedlands Western Australia, 6009, Australia
Nedlands Western Australia, 6009, Australia
Beijing Beijing, 10004, China
Lanzhou Gansu, 73000, China
Guangzhou Guangdong, 51008, China
Guangzhou Guangdong, 51051, China
Shenzhen Guangdong, 51803, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43002, China
Suzhou Jiangsu, 21500, China
Nanchang Jiangxi, 33000, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 30006, China
Hangzhou Zhejiang, 31000, China
Leipzig , 04103, Germany
Seoul Seoul Teugbyeolsi, 03080, Korea, Republic of
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Seoul Seoul Teugbyeolsi, 05505, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Takapuna , 0622, New Zealand
Wellington , 6021, New Zealand
Barcelona , 08025, Spain
Salamanca , 37007, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
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