Immediate versus bridging allogeneic stem cell transplantation for higher-risk myelodysplastic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 randomized study will enroll 236 adults with higher-risk MDS who are eligible for allogeneic hematopoietic stem cell transplantation. Participants are randomized 1:1 to either immediate transplantation or to receive bridging therapy followed by transplantation. The primary design is a non-inferiority comparison and the study will continue until at least 124 events have occurred. Key outcomes include relapse, overall survival, and transplant-related complications to determine the impact of timing and pretransplant disease control.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijin, Beijing Municipality, China Recruiting
• Zhengzhou University First Affiliated Hospital
  Zhengzhou, Henan, China Recruiting
• The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
  Jinan, Shandong, China Recruiting
• People's Liberation Army The General Hospital of Western Theater Command
  Chengdu, Sichuan, China Recruiting
• The Second Hospital of Hebei Medical University
  Shijia Zhuang, China Recruiting

Study contacts

• Study coordinator: Jiang Erlie, doctor
• Email: jiangerlie@ihcams.ac.cn
• Phone: +86-15122538106

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Age-stratified conditioning regimens to improve outcomes in haploidentical stem cell transplant for myelodysplastic syndrome

  This study tests two conditioning regimens in adults with MDS undergoing haploidentical stem cell transplant to see how age affects outcomes over one year.

  Recruiting Phase 2 Peking University People's Hospital · Beijing · NCT07677306

• FXS0683 in relapsed or refractory blood cancers

  This first‑in‑human study tests FXS0683 in adults with relapsed or refractory B‑cell lymphoma, AML, MDS, or ALL to see if it is safe, how the drug behaves in the body, and whether it shows any antitumor activity.

  Recruiting Phase 1 Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Tianjin, Tianjin Municipality · NCT07616089

• Brain network changes in adults with anemia measured by fNIRS

  This project will use functional near-infrared spectroscopy (fNIRS) to see if brain network connections are altered in adults aged 18–65 who have anemia.

  Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07578675

• Cord blood transplant for children and young adults with blood cancers.

  This study will test whether a cord blood transplant given as a first or second transplant can help children and young adults with leukemia, myelodysplasia, or lymphoma who lack a matched donor.

  Recruiting Phase 2 Memorial Sloan Kettering Cancer Center · New York, New York · NCT07566377

• Reduced-intensity donor stem cell transplant with treosulfan/fludarabine and post-transplant cyclophosphamide for leukemia and MDS

  This trial tests a lower-intensity donor stem cell transplant using treosulfan plus fludarabine with post-transplant cyclophosphamide to try to reduce toxicity and prevent graft-versus-host disease in people aged 2–75 with acute leukemias or myelodysplastic syndromes.

  Recruiting Phase 2 Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota · NCT07493538

• Electronic mindfulness-based music therapy for patients receiving stem cell transplantation

  This trial tests an eHealth mindfulness-based music therapy to see if it improves quality of life and reduces symptoms for adults undergoing stem cell transplantation.

  Recruiting University of Miami · Miami, Florida · NCT07469592

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.