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Taking people in ChinaPhase 3

Comparing two melphalan doses before stem cell transplant in leukemia or MDS

Compares two melphalan doses before transplant in adults with AML or MDS.

Plain-language title generated from the registry record
Registry title: Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomized Study of Different Dose of Melphalan

Key facts

Where
Shanghai, ChinaSee the 2 sites
Phase
Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 55 with acute myeloid leukemia in first remission or myelodysplasia syndrome who are about to have a stem-cell transplant and have a donor.

Age
18 to 55 years
Sex
All sexes can join.
Disease stage
Acute myeloid leukemia (AML) in first remission, or myelodysplasia syndrome (MDS) with bone marrow blasts above 5% but under 20% before the transplant.

Main reasons for not taking part

  • Active infection (bacteria, fungal or viral)
  • Abnormal liver function
  • Abnormal kidney function
  • Abnormal heart function

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 55 years old?

Source: NCT06829472, who can take part

Where in China

  • Rui Jin HospitalShanghai, ChinaContact: jiong HUTaking people
  • Zhaxin Hospital, Go Broad Health CareShanghai, ChinaContact: Chun WangNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Shanghai Jiao Tong University School of Medicine
Trial code
NCT06829472
Record updated
17 February 2025
Original description
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.Read full original descriptionShow less

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.

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.

Inclusion: 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.

Exclusion: Patients with active infection (bacteria, fungal or viral); Patients with abnormal liver, renal and cardiac function.

ClinicalTrials.gov NCT06829472