NCT06829472RecruitingPhase 3
Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomized Study of Different Dose of Melphalan
Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomize Study Comparing 100mg/m2 to 140mg/m2 Melphalan for Adult Patients With Acute Myeloid Leukemia or Myelodysplasia Syndrome.
Source: ClinicalTrials.gov · Last updated 17 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Conditioning regimen with melphalan-busulfan and fludarabine (MBF) achieved low relapse rate in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In our previous retrospective study, we demonstrated that melphalan dose at 100 or 140mg/m2 had similar incidence of relapse but it might had lower toxicities. In this prospective randomize study, we aim to compare the transplantation outcome in adult patients with AML/MDS receiving either MBF with 100 or 140 mg/m2 melphalan.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 12 Aug 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- NCT number
- NCT06829472
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 120
- From 1 Dec 2023 to the primary completion date, 1 Jul 2026
- 2 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
- Patients with active infection (bacteria, fungal or viral)
- Patients with abnormal liver, renal and cardiac function
Who the study is looking for
- Patients with AML in first remission
- Patients with MDS with bone marrow blast \>5% but remain less than 20% before transplantation
- Donor available: HLA matched sibling donor, 9\~10/10 matched unrelated donor or haplo-identical donor
- Inform consent provided
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rui Jin Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Zhaxin Hospital, Go Broad Health Care Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.