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Should MDS patients get chemo before a stem cell transplant? new trial aims to find out.

NCT ID NCT06918834

Disease control Sponsor: Institute of Hematology & Blood Diseases Hospital, China Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two strategies for people with higher-risk myelodysplastic syndrome (MDS): getting a donor stem cell transplant right away versus receiving one to two cycles of chemotherapy first (called bridging therapy) before the transplant. The goal is to see if immediate transplant is at least as good as the pre-treatment approach. About 236 adults will take part, and the main outcome is how many are alive and cancer-free two years after transplant.

What this could mean

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

Active substance
allogeneic hematopoietic stem cell transplantation (a donor stem cell transplant) with or without pre-transplant chemotherapy (azacitidine, venetoclax, or targeted drugs)
What this could lead to
If it works, this could show that going straight to transplant is just as effective as pre-treatment, potentially simplifying care and reducing side effects for higher-risk MDS patients.
What could go wrong
This is a Phase 2 trial with 236 participants, so results are still early. The study may not prove one approach is clearly better, and stem cell transplants carry serious risks like infection and graft-versus-host disease.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 236 people

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

Started

Jul 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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. Age ≥18 years 2. High relapse risk MDS, defined by: * IPSS-R score ≥3.5. * IPSS-M stratification as intermediate-high, high, or very high risk. 3. Eligible for allogeneic HSCT (including matched or mismatched related/unrelated donor transplantations). 4. Karnofsky Performance Status (KPS) ≥60. 5. Signed informed consent. Exclusion Criteria: 1. Severe organ dysfunction: * Left ventricular ejection fraction \<50%. * Oxygen supplementation requirement. * Serum bilirubin \>1.5x upper limit of normal (unless due to Gilbert syndrome) or AST/ALT \>5x upper limit of normal. * Estimated glomerular filtration rate (eGFR) \<50 mL/min. 2. History of prior allogeneic HSCT. 3. Any condition deemed unsuitable by the investigator.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University People's Hospital

    RECRUITING

    Beijin, Beijing Municipality, 100044, China

  • People's Liberation Army The General Hospital of Western Theater Command

    RECRUITING

    Chengdu, Sichuan, 610083, China

  • The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army

    RECRUITING

    Jinan, Shandong, China

  • The Second Hospital of Hebei Medical University

    RECRUITING

    Shijia Zhuang, China

  • Zhengzhou University First Affiliated Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

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