A Randomized Clinical Trial Comparing Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL

This is a prospective, multicenter, randomized controlled, open trial. The primary endpoint was 2-year PFS The secondary endpoint was： 2-year overall survival (OS). CR rate at 3 months post-transplant evaluation Hematopoietic reconstitution time Non-recurrent mortality (NRM)

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