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

NCT05991908 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Jiao Tong University School of Medicine

Phase

Phase 3

Started

2023-10-19

Last updated

2025-02-18

Condition(s) studied

Acute Myeloid LeukemiaMyelodysplastic Syndromes

Investigational drug(s) / intervention(s)

Fludarabine, busulfan and melphalanFludarabine and Busulfan

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

Fludarabine and Busulfan: FLudarabine 150mg/m2 + Busulfan 12.8mg.kg

Study summary

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.

Eligibility

Sex

ALL

Min age

16 Years

Max age

55 Years

Healthy volunteers

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

Primary outcome measure(s)

disease-free survival — 2 year
event defined as relapse and death of any causes

Trial sites (9)

Facility	City	Region	Status
Fujian Medical University Union Hospital	Fuzhou	Fujian	Recruiting
Zhongshan Hospital, Xianmen University	Xiamen	Fujian	Recruiting
923th Hospital PLA	Nanning	Guangxi	Recruiting
First Affiliated Hospital of Nanjin Medical Unviersity	Nanjin	Jiangsu	Recruiting
First Affiliatied Hospital of Soochow University	Suzhou	Jiangsu	Recruiting
Ruijin Hospital	Shanghai	Shanghai Municipality	Recruiting
Shanghai No10 Hospital	Shanghai	Shanghai Municipality	Recruiting
920th Hospital PLA	Kunming	China	Recruiting
Shanghai No 6 Hospital	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05991908 on ClinicalTrials.gov ↗ ← All trials in China