NCT05991908RecruitingPhase 3
Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies
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)
Source: ClinicalTrials.gov · Last updated 18 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15\~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (\<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 222 (estimated)
- First submitted
- 8 Aug 2023
- Start date
- 19 Oct 2023
- Primary completion date
- 30 Oct 2025
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- NCT number
- NCT05991908
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 222
- From 19 Oct 2023 to the primary completion date, 30 Oct 2025
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 16 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| 920th Hospital PLA Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| First Affiliated Hospital of Nanjin Medical Unviersity Coordinator of this site? Confirm its status | Nanjin | China | Recruiting |
| 923th Hospital PLA Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Ruijin hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai No 6 Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai No10 Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| First Affiliatied Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Zhongshan Hospital, Xianmen University Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.