Study of decitabine and cedazuridine combination in patients with lower-risk myelodysplastic syndromes

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What is this study about?

This clinical trial focuses on patients with Myelodysplastic Syndromes (MDS), a group of blood disorders where the bone marrow does not produce enough healthy blood cells. The study will test a medication called ASTX727, which contains two active substances: decitabine and cedazuridine. These are given as tablets that are taken by mouth.

The purpose of this study is to evaluate different doses and schedules of ASTX727 in people with lower-risk MDS. The study is divided into two phases. The first phase will determine the safety of different doses and schedules, while the second phase will assess how well the selected doses work in treating the disease.

During the study, participants will take ASTX727 tablets according to a specified schedule. The treatment period may last up to 84 days, during which doctors will monitor the participants’ blood counts and overall health. The study will look at how the medication affects blood cell production and whether it helps reduce the need for blood transfusions. Researchers will also track how the body processes the medication and observe any side effects that may occur.

1 Initial assessment

Your eligibility for the study will be evaluated based on specific medical criteria, including blood test results from the past 8 weeks.

A medical examination will check your liver and kidney function through blood tests.

If you are of childbearing age, a pregnancy test will be performed.

2 Treatment assignment

You will be randomly assigned to receive ASTX727 treatment, which contains two medicines: decitabine and cedazuridine.

The medication will be provided in tablet form for oral use.

3 Treatment period

You will take the medication according to the prescribed schedule.

Regular blood tests will monitor your response to treatment.

Your bone marrow function will be evaluated periodically.

The study team will monitor and record any side effects you may experience.

4 Follow-up assessments

Your blood cell counts will be regularly checked to measure treatment effectiveness.

The medical team will assess your need for blood transfusions during the study.

Bone marrow examinations will be performed to monitor disease status.

5 Study completion

The study is expected to continue until October 2025.

Your participation may end earlier based on your response to treatment or other medical factors.

After completing treatment, you will need to use effective birth control for 3 months (males) or 6 months (females).

Who Can Join the Study?

Must be able to understand the study procedures, risks, and provide informed consent
Must be aged 18 years or older with low or intermediate-1 risk MDS and have at least one of these conditions in the past 8 weeks:
- Need for 2 or more red blood cell transfusions
- Hemoglobin level of 9.0 g/dL or lower in at least 2 blood tests
- Low white blood cell count (neutrophils below 0.5×10^9/L) in at least 2 blood tests
- Low platelet count (below 50×10^9/L) in at least 2 blood tests
Must have an ECOG performance status between 0-2 (ability to perform daily activities)
Must have adequate liver function:
- Bilirubin levels no more than 2 times above normal
- Liver enzymes (AST and ALT) no more than 5 times above normal
Must have adequate kidney function:
- Creatinine levels no more than 1.5 times above normal
- Kidney filtration rate of at least 50 mL/min
Women who can become pregnant must:
- Not be pregnant or breastfeeding
- Have a negative pregnancy test
- Use effective birth control during the study and for 6 months after
Men with partners who can become pregnant must:
- Use condoms during the study
- Have their partners use effective birth control
- Agree not to father a child during treatment and for 3 months after

Who Cannot Join the Study?

Prior treatment with hypomethylating agents (drugs that affect DNA methylation)
Active or uncontrolled systemic infections requiring treatment
Severe heart conditions including uncontrolled high blood pressure, heart failure, or recent heart attack
Severe kidney dysfunction requiring dialysis
Severe liver dysfunction or active liver disease
Known HIV infection
Active hepatitis B or C infection
Other active cancers requiring treatment
Pregnant or breastfeeding women
Unable to swallow oral medications
Participation in other clinical trials within 30 days
Known allergies to the study medication or its components
Mental conditions that could interfere with study compliance
Life expectancy less than 3 months
Blood disorders not related to MDS that could affect study results

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Gasthuiszusters Antwerpen	Antwerp	Belgium
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Mywzpnucmgwmwovxybrtivebaj Hgervxsndeibzgow	Halle (Saale)	Germany
Izylskkz Coozcx Dmgckvygtitaiycwr	L'hospitalet De Llobregat	Spain
Hkrjhsrb Vyfi dsxrmgtm	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	03.05.2021
Germany	Not recruiting	03.05.2021
Spain	Not recruiting	03.05.2021

Trial locations

Investigated drugs:

ASTX727 is an oral medication being studied for the treatment of myelodysplastic syndromes (MDS), a group of blood disorders. It is designed to work by helping to correct abnormal blood cell production in the bone marrow. This medication is being tested specifically in patients with lower-risk MDS, where it may help improve blood cell counts and reduce the need for blood transfusions.

Investigated diseases:

Myelodysplastic syndrome

Myelodysplastic Syndromes (MDS) – A group of blood disorders where the bone marrow does not produce enough healthy blood cells. In MDS, immature blood cells (blasts) fail to develop properly and often die in the bone marrow. This condition affects the production of red blood cells, white blood cells, and platelets. The abnormal blood cells can gradually fill up the bone marrow, leading to decreased production of normal blood cells. MDS can develop gradually over time, and symptoms may include fatigue, frequent infections, and easy bruising or bleeding. The condition primarily affects older adults, though it can occur at any age.

Trial ID:

2024-516296-32-00

Protocol code:

ASTX727-03

NCT ID:

NCT03502668

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of decitabine and cedazuridine combination in patients with lower-risk myelodysplastic syndromes

What is this study about?

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