No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
260 (estimated)
Sponsor
BeOne Medicines · Industry
Who this trial is looking for
This trial is looking for people with certain types of blood cancers like acute myeloid leukemia and myelodysplastic syndromes. Participants will be given a new treatment called BGB-11417 alone or with another drug to see how safe it is and how well it works.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with acute myeloid leukemia, myelodysplastic syndrome, or MDS/MPN.
I have a performance status score between 0 and 2.
My kidney function is acceptable.
I expect to live more than 12 weeks.
I can follow the study requirements.
You may not be able to join if
I have been diagnosed with acute promyelocytic leukemia.
I have a history of other cancers that haven't been cancer-free for 2 years.
I have a condition called myelofibrosis, essential thrombocytosis, or polycythemia vera.
I have had prior treatment with a B-cell lymphoma-2 inhibitor.
I have known leukemia in my brain.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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) .
Trial Locations
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City
State
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Status
Eligibility 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:
* Creati…
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.
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