Trial Title:
Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies
NCT ID:
NCT05991908
Condition:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Syndrome
Vidarabine
Fludarabine
Fludarabine phosphate
Melphalan
Busulfan
Conditions: Keywords:
conditioning regimen, melphalan, busulfan, fludarabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
study group with fludarabine, busulfan and melphalan regimen versus control group with
fludarabine and busulfan
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fludarabine, busulfan and melphalan
Description:
FLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2
Arm group label:
Flu-Bu2-Mel140
Intervention type:
Drug
Intervention name:
Fludarabine and Busulfan
Description:
FLudarabine 150mg/m2 + Busulfan 12.8mg.kg
Arm group label:
Flu-Bu4
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.
Criteria for 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
Gender:
All
Minimum age:
16 Years
Maximum age:
55 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaofan Li
Phone:
8618250490368
Email:
morningshiplee@sina.cn
Facility:
Name:
Zhongshan Hospital, Xianmen University
Address:
City:
Xiamen
Zip:
361004
Country:
China
Status:
Recruiting
Contact:
Last name:
quanyi Lu
Phone:
8613300959425
Email:
luquanyi@xmu.edu.cn
Facility:
Name:
923th Hospital PLA
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaolin Yin
Phone:
8613321717899
Email:
280662268@qq.com
Facility:
Name:
First Affiliatied Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojin Wu
Phone:
861305749353
Email:
wuxiaojin@suda.edu.cn
Facility:
Name:
First Affiliated Hospital of Nanjin Medical Unviersity
Address:
City:
Nanjin
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Kourong Miao
Phone:
8613813828314
Email:
kourongmiao@163.com
Facility:
Name:
Ruijin Hospital
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiong HU
Phone:
8613764313546
Email:
hj10709@rjh.com.cn
Facility:
Name:
Shanghai No10 Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Houcai Wang
Phone:
8618019498303
Email:
houcaiwang@163.com
Facility:
Name:
920th Hospital PLA
Address:
City:
Kunming
Zip:
650000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoping Li
Phone:
8618523894353
Email:
xiaopinllli@163.com
Facility:
Name:
Shanghai No 6 Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
ChunKang Chang
Phone:
8618930177640
Email:
changchunkang0710@aliyun.com
Start date:
October 19, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Source:
Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05991908
