A Randomized Clinical Trial Comparing Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL
Newly Diagnosed Peripheral T-cell Lymphoma
About this trial
This is an interventional treatment trial for Newly Diagnosed Peripheral T-cell Lymphoma focused on measuring PTCL, Chidemide
Eligibility Criteria
Inclusion Criteria: Pathologically diagnosed patients with newly treated PTCL (including NT/ K-cell lymphoma), except for ALK (+), have CR or PR after first-line treatment; Renal function needs to be satisfied: creatinine clearance ≥80ml/min, creatinine less than 160μmol/L; Liver function requirements: ALT and AST≤2 times the upper limit of normal; Total bilirubin ≤2 times the upper limit of normal; Lung function should meet: FEV1, FVC, DLCO≥50% predictive value; Cardiac function must be satisfied: left ventricular ejection fraction ≥50%, asymptomatic arrhythmia. Age between 18 and 65 years old, male and female; ECOG physical strength score 0-1; Neutrophil absolute value ≥1.5×109/L, platelets ≥ 70×109/L, hemoglobin ≥ 90g/L; Number of CD34+ cells ≥ 2.0×106/kg body weight; Expected survival time ≥3 months; Voluntarily sign written informed consent. Exclusion Criteria: Lymphoma involving the central nervous system Active hepatitis B or C virus infection; Active infection; HIV infected persons; Evidence of cirrhosis or liver fibrosis; Ecg showed QTc > 500ms; Persons with mental disabilities/unable to obtain informed consent; Patients with drug or chronic alcohol abuse that may affect the evaluation of study results; Pregnant and lactating women and women of childbearing age who do not want to take contraceptive measures; The researcher determines that it is not suitable to participate in this study
Sites / Locations
- Hematological Department, People's Hospital of Jiangsu ProvinceRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
C-BEAM
BEAM
Chidemide,carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation
carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation