Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies
- Conditions
- Acute Myeloid LeukemiaMyelodysplastic Syndromes
- Interventions
- Drug: Fludarabine, busulfan and melphalan
- Registration Number
- NCT05991908
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 222
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Flu-Bu2-Mel140 Fludarabine, busulfan and melphalan Patients receive fludarabine, busulfan and melphalan as conditioning regimen Flu-Bu4 Fludarabine and Busulfan Patients receive fludarabine and busulfan as conditioning regimen
- Primary Outcome Measures
Name Time Method disease-free survival 2 year event defined as relapse and death of any causes
- Secondary Outcome Measures
Name Time Method overall survival 2 year event defined as death of any causes
incidence of relapse 2 year event defined as disease relapse (bone marrow or extra medullary)
non relapse mortality 2 year event defined as death without disease relapse
Trial Locations
- Locations (9)
Zhongshan Hospital, Xianmen University
🇨🇳Xiamen, Fujian, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
First Affiliated Hospital of Nanjin Medical Unviersity
🇨🇳Nanjin, Jiangsu, China
923th Hospital PLA
🇨🇳Nanning, Guangxi, China
First Affiliatied Hospital of Soochow University
🇨🇳Suzhou, Jiang Su, China
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai No10 Hospital
🇨🇳Shanghai, Shanghai, China
920th Hospital PLA
🇨🇳Kunming, China
Shanghai No 6 Hospital
🇨🇳Shanghai, China