Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a gentler dose of an oral chemo drug help MDS patients avoid transfusions?

NCT ID NCT03502668

Disease control Sponsor: Taiho Oncology, Inc. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested an oral drug called ASTX727 in people with lower-risk myelodysplastic syndromes (MDS), a bone marrow disorder. The goal was to see if a lower dose given over a longer schedule could improve blood cell counts and reduce the need for transfusions. The trial enrolled 160 adults and looked at safety and effectiveness in two phases.

What this could mean

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

Active substance
ASTX727 (oral decitabine and cedazuridine)
What this could lead to
If successful, this could offer a more convenient oral treatment option for people with lower-risk MDS, potentially improving blood cell counts and reducing transfusion needs.
What could go wrong
This is an early-phase trial with small groups, so results may not confirm benefit. The drug can cause side effects like low blood counts or infections.

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

160 people

The number who actually took part.

Started

Jul 2018

Finished

Jan 2026

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. Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure. 2. Men or women ≥18 years with IPSS low risk or Int-1 MDS (all subjects). Subjects must have had at least 1 of the following disease-related criteria during the 8 weeks before randomization: 1. Red blood cell (RBC) transfusion dependence of 2 or more units of RBC transfusions (RBC transfusion administered for hemoglobin (Hb) levels ≤9.0 g/dL are counted). 2. Hb of \<9.0 g/dL in at least 2 blood counts prior to randomization or in 1 blood count if RBC transfusion was received. 3. Absolute Neutrophil Count (ANC) of \<0.5 × 10\^9/L in at least 2 blood counts prior to randomization. 4. Platelet counts of \<50 × 10\^9/L in at least 2 blood counts prior to randomization. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 4. Adequate organ function. 5. Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group \[CTFG\]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. 6. Women of child-bearing potential must agree to use contraceptive measures of birth control for 6 months after completing treatment; men must use contraceptive measures and agree not to father a child for at least 3 months after completing treatment. Exclusion Criteria: 1. Treatment with any investigational drug or therapy within 2 weeks before study treatment. 2. Treatments for MDS must be concluded 1 month prior to study treatment. 3. Prior treatment with azacitidine, decitabine, or guadecitabine. 4. Diagnosis of chronic myelomonocytic leukemia (CMML). 5. Poor medical risk because of other conditions such as uncontrolled systemic diseases or active uncontrolled infections. 6. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, prostate cancer or breast cancer under control with hormone therapy, or other cancer from which the subject has been disease free for at least 1 year. 7. Known active infection with human immunodeficiency virus or hepatitis viruses.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Myelodysplastic syndromes are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Az St-Jan Brugge-Oostende A.V.

    Bruges, Belgium

  • BRCR Medical Center Inc.

    Plantation, Florida, 33324, United States

  • Hospital General Universitario Gregorio Marañón

    Madrid, Spain

  • Hospital Univeristario y Politecnico La Fe Servicio de Hematologia

    Valencia, 46026, Spain

  • Hospital Universitario Vall d Hebron

    Barcelona, Spain

  • Indiana University Health Hospital - Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Institut Català d'Oncologia Badalona Hospital Universitari Germans Trias i Pujol

    Barcelona, Spain

  • London Regional Cancer Center

    London, Ontario, N6A 5W9, Canada

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • Moffitt Cancer Center Site#507

    Tampa, Florida, 33612, United States

  • Oregon Health and Science University Knight Cancer Institute

    Portland, Oregon, 97239, United States

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Texas Oncology - Tyler

    Tyler, Texas, 75702, United States

  • The Center for Cancer and Blood Disorders (RCCA MD LLC - Maryland Division)

    Bethesda, Maryland, 20817, United States

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • The University of Chicago

    Chicago, Illinois, 60637, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Universita degli Studi di Firenze

    Florence, Italy

  • Universitaetsklinikum Freiburg Site#703

    Freiburg im Breisgau, 79106, Germany

  • University of Alberta Hospital - Hematology Research

    Edmonton, T6G 2B7, Canada

  • University of Colorado, Anschutz Cancer Pavilion

    Aurora, Colorado, 80045, United States

  • University of Kansas Clinical Research Center

    Westwood, Kansas, 66205, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • Universitätsklinikum Halle

    Halle, 06120, Germany

  • Vanderbilt University Medical Center - Hematology-Oncology

    Nashville, Tennessee, 37232, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06510, United States

  • ZNA - Campus Middelheim

    Antwerp, Belgium

More trials for these conditions

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