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Recruiting NCT05991908

Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies

Phase III Interventional Acute Myeloid Leukemia Myelodysplastic Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fludarabine, busulfan and melphalan, Fludarabine and Busulfan.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes. Basic parameters: 16 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Detailed description

Fludarabine and busulfan was considered as myeloablative but reduced toxicity regimen and became as the mainstay of conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The disease relapse remained as major cause of treatment failure. In general, the cumulated incidence of relapse (CIR) is about 15\~20% dependent on the risk of patients undergoing allogeneic stem cell transplantation (allo-HSCT). Conditioning regimen with dual alkylating agents such as fludarabine, busulfan and thiotepa (TBF) showed decreased risk of relapse in myeloid malignancies. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan could achieve a low incidence of relapse (2 year CIR \<10%). In this multiple-center randomize study, the aim is to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu vs. Flu-Bu-Mel.

Interventions

  • Drug Fludarabine, busulfan and melphalan
    FLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2
  • Drug Fludarabine and Busulfan
    FLudarabine 150mg/m2 + Busulfan 12.8mg.kg

Primary outcome measures

  • disease-free survival [Time frame: 2 year]
Secondary outcome measures (4)
  • overall survival [Time frame: 2 year]
  • incidence of relapse [Time frame: 2 year]
  • non relapse mortality [Time frame: day 100]
  • non relapse mortality [Time frame: 2 year]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 9 centers
  • Fujian Medical University Union Hospital — Fuzhou
  • Zhongshan Hospital, Xianmen University — Xiamen
  • 923th Hospital PLA — Nanning
  • First Affiliated Hospital of Nanjin Medical Unviersity — Nanjin
  • First Affiliatied Hospital of Soochow University — Suzhou
  • Ruijin Hospital — Shanghai
  • Shanghai No10 Hospital — Shanghai
  • 920th Hospital PLA — Kunming
  • … and 1 more center

Identifiers

NCT: NCT05991908 · MBF-FB4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗