Reduced intensity conditioning for older patients with myeloid malignancies
Official title: A Multiple-center Phase II Study to Evaluate the Clinical Outcome of Reduced Conditioning Regimen With Melphalan, Busulfan and Fludarabine for Patients >=55 Years With Myeloid Malignancies.
Run by Shanghai Jiao Tong University School of Medicine · NCT05436561 · Data updated 2026-11-12
This study is testing a gentler treatment plan for older patients with blood cancers to see if it helps them live longer and healthier after a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 55 Years to 65 Years |
| Sex | All |
| Enrollment | 61 (estimated) |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | fludarabine |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Status | Recruiting |
| Started | June 1, 2022 |
| Main results expected | December 1, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | March 17, 2026 |
| Trial ID | NCT05436561 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 55-65 with myeloid malignancies who have HLA-matched donors.
✕Probably not a fit
Patients with significant liver, renal, or cardiac dysfunction, or those with active infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II clinical trial evaluates the effectiveness of a reduced intensity conditioning regimen using fludarabine, busulfan, and melphalan in patients aged 55 and older with myeloid malignancies such as AML, MDS, and CMML. The study aims to improve disease-free survival rates by utilizing a combination of double alkylating agents to enhance transplantation outcomes. Participants will be recruited from multiple centers and must have suitable HLA-matched donors. The trial will assess the clinical outcomes associated with this treatment approach.
Why it matters
Potential benefit: If successful, this study could lead to improved disease-free survival rates for older patients with myeloid malignancies.
How similar studies have gone: Other studies have shown that reduced intensity conditioning regimens can improve transplantation outcomes in similar patient populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 55-65 * patients with HLA-matched sibling donors, 9-10/10 matched unrelated donors or haplo-identical donors. * patients with AML in remission, or MDS in any stage, or CMML in any stage * inform consent provided Exclusion Criteria: * patients with abnormal liver (\>3N), renal (1.5N) or cardiac function * patients with active infection
Where it's running
-
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai Municipality, China Recruiting -
Shanghai No 6 Hospital
Shanghai, China Recruiting
Study contacts
- Principal investigator: Jiong Hu — Shanghai Jiao Tong University School of Medicine
- Study coordinator: Jieling Jiang
- Email: jiangjieling66@hotmail.com
- Phone: +8613311986505
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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.