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Taking people in ChinaPhase 3

Comparing two chemotherapy preparations before stem cell transplant in leukemia and MDS

Compares two pre-transplant chemotherapy regimens in adults with acute myeloid leukemia or MDS.

Plain-language title generated from the registry record
Registry title: Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies

Key facts

Where
Fuzhou, Kunming, Nanjin, Nanning, Shanghai, Suzhou, and Xiamen, ChinaSee the 9 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 with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are going to have a stem cell transplant. It compares two kinds of pre-transplant chemotherapy.

Age
16 to 55 years
Sex
All sexes can join.
Disease stage
AML in first complete remission (acute promyelocytic leukemia is not included), or MDS with bone marrow blasts above 5% and under 20% at the time of transplant.

Main reasons for not taking part

  • AML with active central nervous system or extramedullary disease
  • Active viral, bacterial or fungal infection
  • Hepatitis B virus above 1X103 copy/ml
  • Abnormal liver or kidney function, or lung or heart problems
  • HIV

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 16 and 55 years old?

Source: NCT05991908, who can take part

Where in China

  • Fujian Medical University Union HospitalFuzhou, ChinaContact: Xiaofan LiTaking people
  • 920th Hospital PLAKunming, ChinaContact: Xiaoping LiTaking people
  • First Affiliated Hospital of Nanjin Medical UnviersityNanjin, ChinaContact: Kourong MiaoTaking people
  • 923th Hospital PLANanning, ChinaContact: Xiaolin YinTaking people
  • Ruijin hospitalShanghai, ChinaContact: Jiong HUTaking people
  • Shanghai No 6 HospitalShanghai, ChinaContact: ChunKang ChangTaking people
  • Shanghai No10 HospitalShanghai, ChinaContact: Houcai WangTaking people
  • First Affiliatied Hospital of Soochow UniversitySuzhou, ChinaContact: Xiaojin WuTaking people
  • Zhongshan Hospital, Xianmen UniversityXiamen, ChinaContact: quanyi LuTaking people

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
NCT05991908
Record updated
18 February 2025
Original description
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.Read full original descriptionShow less

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)

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT05991908