Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This is a non-randomised, open-label trial with two cohorts: one for patients with acute myeloid leukaemia (AML) and one for patients with myelodysplastic syndromes (MDS). Both cohorts will receive treatments in two phases. Phase one is testing two different treatment cycles of BGB-11417 (orally) and azacitidine (via intravenous [IV] or subcutaneous [SC] injection). In Phase 2, the cycle determined in the initial phase will be applied, or a subset of patients may receive a modified treatment.
Conditions
This trial is treating people with acute myeloid leukaemia and myelodysplastic syndromes
Eligibility
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
- 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.
Inclusion
- You are able to swallow medication by mouth.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene Australia Pty Ltd
Scientific Title
A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies
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