At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- BGB-11417 (drug), Azacitidine (drug), Posaconazole (drug), BGB-11417 (drug)
- How long the study runs
- Study runs about 87 months (dates as stated)
- About the drug or intervention
- BGB-11417 — drug: Oral administration for 10, 21, 14 or 28 days on a 28-day cycle. · Azacitidine — drug: Intravenous or subcutaneous administration for 7 days. · Posaconazole — drug: Oral administration for 8 days on second cycle only. · BGB-11417 — drug: Oral administration for 28 days on a 28-day cycle. · BGB-11417 — drug: Oral administration for 10, 14 or 21 days on a 28-day
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 260
- Started
- 2021-05-24
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for acute myeloid leukemia
- • Phase1/Phase2 - 260 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with acute myeloid leukemia
Where?
- • Edinburgh - Edinburgh Cancer Centre
- • Greater Manchester - The Christie Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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) .
More detail
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Acute Myeloid LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasm
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
- ✓AML, nonacute promyelocytic leukemia
- ✓MDS/MPN
- ✓activity scale performance status of 0 to 2.
- ✓healthy organ defined as:
Who cannot take part
- ✗A diagnosis of acute promyelocytic leukemia.
- ✗Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia...
- ✗Prior therapy with a B-cell lymphoma-2 inhibitor
- ✗Known central nervous system involvement by leukemia.
- ✗Note: Other protocol defined Inclusion/Exclusion criteria may apply.
See the full criteria
Key Inclusion Criteria:
1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
* AML, nonacute promyelocytic leukemia
* MDS
* MDS/MPN
2. Eastern Cooperative Oncology Group performance status of 0 to 2.
3. 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
4. Life expectancy of \> 12 weeks.
5. Ability to comply with the requirements of the study.
Key Exclusion Criteria:
1. A diagnosis of acute promyelocytic leukemia.
2. History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)
3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
4. Prior therapy with a B-cell lymphoma-2 inhibitor
5. Known central nervous system involvement by leukemia.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where Is This Study? (2 UK sites)
Edinburgh Cancer Centre
Edinburgh EH4 2XU, United Kingdom
The Christie Hospital
Greater Manchester M20 4BX, United Kingdom
How to Get in Touch
Study Director
Sponsor contactCONTACT
1.877.828.5568 clinicaltrials@beonemed.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09