ASTX727 + Iadademstat for Myeloproliferative Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a drug combination for individuals with Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs) that have advanced. Researchers compare the effects of ASTX727, which aids in creating normal blood cells, both alone and combined with iadademstat, an experimental treatment that may inhibit cancer cell growth. The goal is to determine if the combination is more effective than ASTX727 alone. Individuals with accelerated or blast-phase MPNs who have not previously used certain cancer drugs may qualify for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial does not require you to stop taking all your current medications, but you cannot take certain antidepressants like tranylcypromine or phenelzine, and some other specific drugs. You can continue using medications like hydroxyurea until 24 hours before starting the trial treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that ASTX727, a combination of cedazuridine and decitabine, is safe and well-tolerated. Reports suggest it works as well as other treatments for certain blood cancers. No major safety issues have emerged, making it a promising option for patients.
Early results for the combination of ASTX727 and another drug, iadademstat, are positive. Research indicates that no serious side effects have been observed that would prevent dose escalation, suggesting the combination is generally safe for patients. It is important to note that this information comes from ongoing research, which helps ensure the treatment's safety and effectiveness for those considering participation in clinical trials.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for myeloproliferative disorders, which often include therapies like hydroxyurea and interferon, ASTX727 offers a unique approach. ASTX727 combines two active ingredients, decitabine and cedazuridine, to inhibit DNA methylation, potentially leading to more targeted and effective results. Researchers are particularly excited about the combination of ASTX727 with iadademstat in one of the trial arms. Iadademstat targets LSD1, an enzyme involved in gene regulation, which may enhance the effectiveness of treatment and address resistance seen in other therapies. This novel approach could offer new hope for patients not responding well to existing options.
What evidence suggests that this trial's treatments could be effective for myeloproliferative disorders?
Research has shown that ASTX727, a combination of cedazuridine and decitabine, helps the body produce healthy blood cells while targeting unhealthy ones. In this trial, some participants will receive ASTX727 alone, while others will receive it with iadademstat. Studies have found promising results, especially when ASTX727 is combined with other medications for patients with serious conditions. Specifically, when paired with iadademstat, the results are even more encouraging. In a small group of patients, 100% responded to the treatment, and 88% achieved complete remission, with no signs of the disease. These findings suggest that adding iadademstat to ASTX727 could enhance its effectiveness in treating certain blood disorders.46789
Who Is on the Research Team?
Anand A Patel
Principal Investigator
City of Hope Comprehensive Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for adults with advanced Philadelphia chromosome negative myeloproliferative neoplasms (MPNs) in accelerated or blast phase. Participants must have a specific level of disease severity, be able to perform basic activities (ECOG ≤ 3), and have normal organ function. Prior treatment with certain drugs is allowed, but not demethylating agents like DNMTi. People with well-managed HIV or hepatitis B can join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ASTX727 with or without iadademstat in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ASTX727
- Iadademstat
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor