Oral Azacitidine for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial studies the best dose and effects of oral azacitidine in patients with T-cell large granular lymphocytic leukemia that has come back or did not respond to previous treatments. Azacitidine is a chemotherapy drug that stops cancer cells from growing, dividing, or spreading.
Do I need to stop my current medications for the trial?
The trial requires that you stop any current treatments for at least 14 days or 5 half-lives (the time it takes for the drug's concentration to reduce by half), whichever is longer, before starting the trial. However, if you are on stable, low-dose prednisone (10 mg or less) for certain conditions, you may continue it.
Is Oral Azacitidine safe for humans?
Azacitidine, also known as Vidaza, has been shown to be generally safe in humans, with studies indicating it is well-tolerated in patients with conditions like myelodysplastic syndromes and acute myeloid leukemia. While some side effects may occur, the overall safety profile is acceptable, especially in older patients.12345
What makes the drug Oral Azacitidine unique for treating leukemia?
Oral Azacitidine is unique because it offers a convenient oral administration compared to the traditional subcutaneous or intravenous injections, potentially reducing side effects and improving patient comfort. This oral form has been developed to overcome previous challenges with rapid breakdown in the body, making it a novel option for patients with leukemia.13467
What data supports the effectiveness of the drug Oral Azacitidine for Leukemia?
Azacitidine, a component of Oral Azacitidine, has been shown to be effective in treating higher-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), as it can prolong survival and improve remission rates compared to conventional care. It is well-tolerated and has been used successfully in real-world settings for these conditions.12346
Who Is on the Research Team?
Jonathan E. Brammer, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Adults with relapsed or refractory T-cell large granular lymphocytic leukemia who need treatment and have not used certain drugs like 5-azacytidine. They must be able to consent, have a decent performance status, meet specific blood count criteria, agree to use birth control, and be off previous treatments for a set time. Those with active infections or on immune-suppressive therapy (beyond low-dose prednisone) are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive oral azacitidine on days 1-14 of a 28-day cycle for a minimum of 4 cycles. Patients with a response continue treatment for up to 12 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oral Azacitidine
Oral Azacitidine is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
John Reneau
Lead Sponsor
Jonathan Brammer
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania