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
Trial Overview
The study compares ASTX727 alone versus ASTX727 combined with iadademstat in treating MPNs. ASTX727 includes cedazuridine and decitabine, which help produce healthy blood cells and kill abnormal ones. Iadademstat may block enzymes that tumor cells need to grow.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients receive ASTX727 PO QD on days 1-5 and iadademstat PO QD on days 1-5, 8-12, 15-19, and 22-26 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo buccal swab sample collection at baseline and blood sample collection and bone marrow aspiration and biopsy throughout the study.
Patients receive ASTX727 PO QD on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo buccal swab sample collection at baseline and blood sample collection and bone marrow aspiration and biopsy throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Taiho Oncology and Astex Pharmaceuticals Present ...
The median OS (mOS) in patients treated with ASTX727 with biallelic vs. monoallelic mutations was 13.0 months (95% Confidence Interval [CI]: 5.3 ...
S172: PHASE 1/2 STUDY OF ORAL DECITABINE ...
The combination of ASTX727 plus venetoclax is a promising, fully oral combination that is well-tolerated and demonstrates a high response rate in higher-risk ...
NCT06661915 | A Randomized Study of ASTX727 With or ...
This phase II trial compares the effect of ASTX727 in combination with iadademstat to ASTX727 alone in treating patients with accelerated or blast phase ...
4.
oryzon.com
oryzon.com/en/news-events/news/oryzon-announces-positive-clinical-data-iadademstat-ash-2025ORYZON announces positive clinical data of iadademstat ...
The overall response rate (ORR) was 100% (n=8), with 88% achieving complete remission (CR), and 12.5% morphologic leukemia-free state (MLFS).
Phase 2 study of ASTX727 (cedazuridine/decitabine) plus ...
Results: Between March 2021 and January 2022, 28 pts (15 FL and 13 R/R) have been treated on the study. The median age is 75 yrs (range, 47-90) ...
NCT06661915 | A Randomized Study of ASTX727 With or ...
This phase II trial compares the effect of ASTX727 in combination with iadademstat to ASTX727 alone in treating patients with accelerated or blast phase ...
Phase II trial of 10-day ASTX727 (decitabine/cedazuridine ...
Conclusions: The 10-day ASTX727-VEN combination showed safety profile comparable to other HMA-VEN regimens in salvage setting. TP53 wild type, ...
Oral cedazuridine/decitabine for MDS and CMML: a phase ...
This phase 2 study was designed to compare systemic decitabine exposure, demethylation activity, and safety in the first 2 cycles with cedazuridine 100 mg/ ...
MDS-634 Efficacy and Safety of Oral Decitabine ...
DEC/CED has clinical benefit in CMML patients with a well-tolerated safety profile. TI may be associated with longer survival.
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