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Could a pill replace IV therapy for MDS? new study investigates

NCT ID NCT06091267

Disease control Sponsor: Otsuka Beijing Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares an oral drug (ASTX727) to an intravenous (IV) drug (decitabine) in 72 Chinese adults with myelodysplastic syndromes (MDS), a bone marrow disorder. Participants will receive both treatments in a crossover design to see if the pill works as well as the infusion. The goal is to find a more convenient treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ASTX727 (decitabine and cedazuridine)
What this could lead to
If it works, this could offer a more convenient oral treatment option for myelodysplastic syndromes, potentially replacing the need for IV infusions.
What could go wrong
This is an early-phase study with only 72 participants, so results may not be conclusive. The oral drug might not be as effective or could have different side effects than the IV version.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Agree to participate in this trial and voluntarily sign the informed consent form. 2. Men or women ≥ 18 years at the time of signing the informed consent form. 3. Subjects with MDS previously treated or untreated with de novo or secondary MDS. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening. Exclusion Criteria: 1. Prior treatment with more than 1 cycle of azacitidine or decitabine. 2. Cytotoxic chemotherapy or prior azacitidine or decitabine within 4 weeks of first dose of study treatment. 3. Conditions as judged by the investigator to be inappropriate for participation in the clinical trial. 4. Previous diagnosis of malignant tumor. 5. History of immune deficiency. 6. Acute myeloid leukemia (AML) with bone marrow or peripheral blast count ≥ 20% or other malignant hematological diseases.

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Conditions

The condition(s) this trial relates to.

myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelodysplastic syndromes

Contacts and locations

Locations

  • The First Affiliated Hospital,Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.