BGB-11417 for Acute Myeloid Leukemia and Myelodysplastic Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, BGB-11417, alone and with azacitidine, in patients with certain blood cancers to see if it is safe and effective, and to find the best dose.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
Is BGB-11417 (Azacitidine) safe for humans?
Azacitidine, often used with venetoclax, has been studied for safety in patients with acute myeloid leukemia and myelodysplastic syndromes. Common side effects include low blood cell counts, which can lead to infections, anemia (low red blood cells), and bleeding issues. Overall, it is considered safe for use in patients who cannot undergo intensive chemotherapy, but monitoring for these side effects is important.12345
What makes the drug BGB-11417 unique for treating acute myeloid leukemia and myelodysplastic syndrome?
BGB-11417, combined with Azacitidine, is unique because it potentially offers a novel mechanism of action or combination that could enhance treatment effectiveness for acute myeloid leukemia and myelodysplastic syndrome, compared to Azacitidine alone, which is already known for prolonging survival in these conditions.46789
What data supports the effectiveness of the drug BGB-11417 for treating Acute Myeloid Leukemia and Myelodysplastic Syndrome?
Who Is on the Research Team?
David Simpson, MD
Principal Investigator
BeiGene
Are You a Good Fit for This Trial?
This trial is for adults with certain blood disorders like AML, MDS, or MDS/MPN. They should be relatively active (able to care for themselves), have kidneys and liver working well, and expected to live more than 12 weeks. People can't join if they've had leukemia in the brain, certain other cancers in the last 2 years, specific blood diseases including myelofibrosis or polycythemia vera, or previous treatments with similar drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BGB-11417 as monotherapy or in combination with azacitidine on a 28-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Azacitidine
- BGB-11417
Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:
- Acute myeloid leukemia
- Chronic myelomonocytic leukemia
- Myelodysplastic syndromes
- Myelodysplastic syndromes
- Chronic myelomonocytic leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
BeiGene
Lead Sponsor