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).

View Eligibility Criteria

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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

260

Study ID:

NCT04771130

Recruitment Status:

Recruiting

Sponsor:

BeiGene

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There are 23 Locations for this study

See Locations Near You

MD Anderson Cancer Center
Houston Texas, 77030, United States
Pindara Private Hospital
Benowa , 4217, Australia
Gold Coast University Hospital
Gold Coast , 4215, Australia
Austin Hospital
Heidelberg , 3084, Australia
The Alfred Hospital
Melbourne , 3004, Australia
St. Vincent's Hospital Melbourne
Melbourne , 3065, Australia
Monash Health
Melbourne , 3168, Australia
Fiona Stanley Hospital
Murdoch , 6150, Australia
One Clinical Research
Nedlands , 6009, Australia
Orange Health Service
Orange , 2800, Australia
Linear Clinical Research
Perth , 6009, Australia
Concord Hospital
Sydney , 2139, Australia
St. George Hospital
Sydney , 2217, Australia
John Flynn Hospital
Tugun , 4224, Australia
Peking University People's Hospital
Beijing , 10004, China
West China Hospital Sichuan University
Chengdu , 61004, China
Nanfang Hospital
Guangzhou , 51051, China
The First Affiliated hospital of Nanchang University
Nanchang , 33000, China
Union Hospital affiliated to Tongji Medical College of Huazhong University
Wuhan , 43002, China
North Shore Hospital
Auckland , 0620, New Zealand
Middlemore Hospital
Auckland , 2025, New Zealand
Wellington Regional Hospital
Wellington , 6021, New Zealand
Hospital Universitario Virgen del Rocío
Sevilla , 41013, Spain
Hospital Politecnico Universitario La Fe
Valencia , 46026, Spain

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

260

Study ID:

NCT04771130

Recruitment Status:

Recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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