Oral Azacitidine for Myelodysplastic Syndrome
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Oral Azacitidine for Myelodysplastic Syndrome?
Is Oral Azacitidine safe for humans?
Azacitidine, also known as Vidaza, has been shown to be generally safe in humans, with common side effects including nausea, vomiting, diarrhea, and low blood cell counts. Serious side effects like liver function abnormalities and renal failure have been reported but are less common. No deaths have been directly attributed to azacitidine in studies.12356
What makes the drug Oral Azacitidine unique for treating Myelodysplastic Syndrome?
Oral Azacitidine is unique because it offers a convenient oral administration compared to the traditional injectable form, potentially improving patient comfort and adherence to treatment. It also allows for flexible dosing schedules, which can be beneficial for long-term management of Myelodysplastic Syndrome.15678
Research Team
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Eligibility Criteria
This trial is for people with a specific blood disorder called Myelodysplastic Syndrome (MDS) that's not too advanced. They should be able to do daily activities on their own or with little help, and haven't been treated with drugs like azacitidine before. People who've had other cancers must be in good health and not have received cancer treatment recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral azacitidine or placebo plus best supportive care
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term outcomes such as overall survival and event-free survival
Treatment Details
Interventions
- Oral Azacitidine
- Placebo for Oral Azacitidine
Oral Azacitidine is already approved in United States, European Union for the following indications:
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
- Juvenile Myelomonocytic Leukemia
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
- Juvenile Myelomonocytic Leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead 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