Evaluating a new treatment for high-risk myelodysplastic syndromes using stem cell transplantation
A Prospective, Single-arm Clinical Study to Evaluate the Efficacy and Safety of Allogeneic Haematopoietic Stem Cell Transplantation With FLU-BU-MEL Conditioning for Myelodysplastic Syndromes
This study is testing a new treatment using stem cell transplants to see if it can help people with high-risk myelodysplastic syndromes live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 59 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Fludarabine, cyclophosphamide |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06247917 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the safety and efficacy of a conditioning regimen involving Fludarabine, Busulfan, and Melphalan (FBM) for allogeneic hematopoietic stem cell transplantation in patients with untreated myelodysplastic syndromes (MDS) that are classified as high-risk. The trial consists of three phases: screening, therapy, and follow-up, where patients undergo thorough evaluations before receiving the treatment and are monitored for safety and efficacy post-transplant. The goal is to determine if this approach can improve survival outcomes for patients with high-risk MDS.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with myelodysplastic syndromes who have not received any prior anti-tumor therapies.
Not a fit: Patients with chronic myelomonocytic leukemia (CMML) with specific genetic alterations or those with secondary MDS may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients with high-risk myelodysplastic syndromes.
How similar studies have performed: While there is limited data from similar studies, previous investigations suggest that early allogeneic stem cell transplantation may improve survival in high-risk MDS patients, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis: Myelodysplastic Syndromes (IB1/IB2) 2. Patients did not receive any anti-tumour therapy (including chemotherapy, immunotherapy (lenalidomide, etc.), targeted therapy, hormone therapy, etc.). Exclusion Criteria: 1. CMML with 5q deletion or carrying PDGFRB fusion gene; 2. secondary MDS;
Where this trial is running
Shanghai
- Ruijin Hospital, Shanghai JiaoTong University School of Medicine — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Luxiang Wang — Ruijin Hospital
- Study coordinator: Xiaoxia Hu
- Email: hu_xiaoxia@126.com
- Phone: +86 021 64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.