Age-stratified conditioning regimens to improve outcomes in haploidentical stem cell transplant for myelodysplastic syndrome
Official title: Prospective Cohort Study of Age-Stratified Busulfan-Based Conditioning Regimens in Adult Patients With Myelodysplastic Syndrome Receiving Haploidentical Hematopoietic Stem Cell Transplantation
Run by Peking University People's Hospital · NCT07677306 · Data updated 2026-11-12
This study tests two conditioning regimens in adults with MDS undergoing haploidentical stem cell transplant to see how age affects outcomes over one year.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | July 15, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT07677306 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with low- or intermediate-risk MDS without ISD or URD who are planned for haploidentical stem cell transplantation.
✕Probably not a fit
Patients with high-risk MDS, active infection, organ failure, or poor ability to comply may not benefit and could be at higher risk from conditioning toxicity.
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 interventional trial enrolls adults with myelodysplastic syndrome who are planned for T-cell-replete haploidentical hematopoietic stem cell transplantation. Participants aged 55 and older receive a reduced-toxicity Bu/Flu/Cy/ATG conditioning, while those younger than 55 receive a standard myeloablative Bu/Cy+ATG regimen, followed by uniform post-transplant care. The study prospectively characterizes 1-year transplant-related mortality and evaluates engraftment, graft-versus-host disease, infection, relapse, survival, and conditioning-related organ toxicity. Primary aim is to understand how age-stratified conditioning influences transplant-related outcomes across all enrolled patients. Safety and feasibility data will inform future optimization of conditioning for haploidentical transplants in MDS.
Why it matters
Potential benefit: If successful, the approach could improve survival and reduce transplant-related toxicity for adults with MDS undergoing haploidentical transplantation.
How similar studies have gone: Prior studies in haploidentical transplantation support the feasibility and safety of varied conditioning regimens, but age-stratified approaches for outcome optimization are less established and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who had low- and intermediate-risk MDS without ISD nor URD receiving haploidentical hematopoietic stem cell transplantation Exclusion Criteria: * Patients having ISD or URD; patients having high-risk MDS; patients with active infection; patients with poor compliance; patients with organ failure
Where it's running
-
Peking University People's Hospital, Beijing Lu Daopei Hematology Hospital, Hebei Yanda Lu Daopei Hospital, Nanfang Hospital, Southern Medical University
Beijing, China Recruiting
Study contacts
- Principal investigator: Xiao-Jun Huang — Peking University Institute of Hematology
- Study coordinator: Yu Wang
- Email: ywyw3172@sina.com
- Phone: 8610-8832-6005
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
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.
-
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.
-
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.
-
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.
-
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.
-
TAK-226 for anemia in lower-risk MDS in Japanese patients
This trial tests TAK-226 to see if it improves transfusion-dependent anemia in Japanese adults with lower-risk myelodysplastic syndromes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.