Study on ASTX727 With or Without Iadademstat for Advanced Myeloproliferative Neoplasms (MPNs)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06661915

Provider View

This clinical trial is testing whether a combination of two drugs, ASTX727 and iadademstat, is more effective than ASTX727 alone in treating advanced myeloproliferative neoplasms (MPNs), a type of blood cancer. The study aims to see if the combination can better control the disease.

Patient Parameters

Program Overview

This study is exploring the effectiveness of a drug combination, ASTX727 and iadademstat, compared to ASTX727 alone in treating patients with advanced stages of myeloproliferative neoplasms (MPNs) that do not have the Philadelphia chromosome. ASTX727 is a mix of two drugs, cedazuridine and decitabine, which work together to help the bone marrow produce normal blood cells and kill abnormal ones. Iadademstat may help stop tumor growth by blocking certain enzymes. The study aims to find out if the combination of these drugs is more effective than ASTX727 alone.

Description

The main goal of this study is to compare how well the combination of iadademstat and ASTX727 works against ASTX727 alone in treating advanced myeloproliferative neoplasms (MPNs). Researchers will look at how many patients achieve a complete response to the treatment within four cycles. They will also compare how long patients live without the disease getting worse and how many go on to receive a stem cell transplant.

The study is divided into two groups. In one group, patients will take ASTX727 by mouth once a day for five days in a 28-day cycle. In the other group, patients will take both ASTX727 and iadademstat by mouth on a specific schedule within the 28-day cycle. Patients will have regular check-ups, including blood tests and bone marrow exams, to monitor their response to the treatment.

After finishing the treatment, patients who stop for reasons other than disease progression will have follow-up visits every three months. Those who stop due to disease progression will have follow-ups every six months.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of advanced myeloproliferative neoplasms (MPNs) without the Philadelphia chromosome, or certain related conditions, with a specific percentage of abnormal cells.
  • Must not have received previous treatment with DNA methyltransferase inhibitors (DNMTi).
  • Must be 18 years or older.
  • Must have a performance status that allows for daily activities with some limitations.
  • Must have adequate liver and kidney function as shown by specific blood tests.
  • Must not have active HIV, hepatitis B, or hepatitis C infections unless well-controlled.
  • Women of childbearing potential must use effective birth control during and for six months after the study.
  • Must be able to swallow pills and have a body weight of at least 50 kg.
  • Must have a white blood cell count below a certain level before starting treatment.

Exclusion Criteria

  • Must not have unresolved side effects from previous cancer treatments, except for hair loss.
  • Must not be taking other experimental drugs or have taken them recently.
  • Must not have a specific heart condition or be taking certain antidepressants.
  • Must not have a specific genetic mutation in their cancer cells.
  • Must not be pregnant or breastfeeding due to potential risks to the baby.
  • Must not have any serious uncontrolled medical conditions that could make participation unsafe.

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