Comparing conditioning regimens for patients with acute myeloid leukemia or myelodysplastic syndromes
Multiple-center Randomized Study to Compare Fludarabine and Busulfan Versus Fludarabine, Busulfan and Melphalan in Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplasia Syndrome (MDS)
This study is testing two different treatment plans for adults with acute myeloid leukemia or myelodysplastic syndromes to see which one helps prevent the disease from coming back after a stem cell transplant.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 222 (estimated) |
| Ages | 16 Years to 55 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | Fludarabine |
| Locations | 9 sites (Fuzhou, Fujian and 8 other locations) |
| Trial ID | NCT05991908 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the outcomes of two different conditioning regimens for adult patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing allogeneic stem cell transplantation (allo-HSCT). One regimen consists of fludarabine and busulfan, while the other includes fludarabine, busulfan, and melphalan. The goal is to determine which regimen results in a lower incidence of disease relapse post-transplantation. The study is conducted across multiple centers and involves random assignment of participants to each treatment group.
Who should consider this trial
Good fit: Ideal candidates include adults with AML in first complete remission or MDS with specific bone marrow blast percentages, who have suitable HLA-matched donors.
Not a fit: Patients with active infections, certain organ dysfunctions, or those with specific viral infections like HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved transplantation outcomes and lower relapse rates for patients with AML and MDS.
How similar studies have performed: Previous studies have shown promising results with dual alkylating agent regimens, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission * myelodysplasia syndrome with bone marrow blast \>5% and remaining less than 20% at transplantation * patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identical related donors * inform consent provided Exclusion Criteria: * AML patients with active CNS or extramedullary diseases * patients with active viral, bacterial or fungal infection * patients with hepatitis B virus \>1X103 copy/ml * patients with abnormal liver function, renal function, respiratory or cardiac dysfunction * patients with uncontrolled mental disorders * patients with HIV
Where this trial is running
Fuzhou, Fujian and 8 other locations
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
- Zhongshan Hospital, Xianmen University — Xiamen, Fujian, China (Recruiting)
- 923th Hospital PLA — Nanning, Guangxi, China (Recruiting)
- First Affiliated Hospital of Nanjin Medical Unviersity — Nanjin, Jiangsu, China (Recruiting)
- First Affiliatied Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
- Ruijin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanghai No10 Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- 920th Hospital PLA — Kunming, China (Recruiting)
- Shanghai No 6 Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Chun Wang — Go Broad Health Center, Zhaxin Hospital
- Study coordinator: chun Wang
- Email: wangchunsh@126.com
- Phone: 13386259777
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.