Comparing conditioning regimens for patients with acute myeloid leukemia or myelodysplastic syndromes
Official title: 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)
Run by Shanghai Jiao Tong University School of Medicine · NCT05991908 · Data updated 2026-11-12
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 |
| Ages | 16 Years to 55 Years |
| Sex | All |
| Enrollment | 222 (estimated) |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | Fludarabine |
| Locations | 9 sites (Fuzhou, Fujian and 8 other locations) |
| Status | Recruiting |
| Started | October 19, 2023 |
| Main results expected | October 30, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | February 18, 2025 |
| Trial ID | NCT05991908 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with active infections, certain organ dysfunctions, or those with specific viral infections like HIV 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 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.
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 gone: Previous studies have shown promising results with dual alkylating agent regimens, suggesting potential for success in this approach.
Who can join: the full rules
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 it's running
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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
Show 3 more locations
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing two conditioning regimens for haploidentical stem cell transplantation
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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.
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CD33-armed immune cell treatment for adults with MRD-positive AML or MDS
This treatment will try giving adults with MRD-positive AML or MDS infusions of their own T cells coated with a CD33-directed bispecific antibody together with standard hypomethylating therapy (and possibly venetoclax) to see if it is safe and lowers residual disease.
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This trial tests whether adding venetoclax to induction and consolidation chemotherapy (fludarabine, cytarabine, and idarubicin) helps adults 18–65 with newly diagnosed acute myeloid leukemia or high-blast myelodysplastic syndrome achieve deeper remissions than standard cytarabine/daunorubicin therapy.
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Venetoclax-enhanced BUCY versus standard BUCY conditioning for high‑risk AML and MDS before allogeneic stem cell transplant
This will test whether adding venetoclax to BUCY conditioning before allogeneic stem cell transplant helps patients aged 12–60 with high‑risk AML or MDS stay in remission longer.
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.