Overview
The goal of this clinical trial is to compare Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL.
The main question it aims to answer are:
•Whether Chi-BEAM improves patient survival compared to BEAM group Participants will be given BEAM or Chi-BEAM before ASCT. Researchers will compare the efficacy and safety of the two groups.
Description
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)
Eligibility
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