A Randomized Controlled Clinical Trial Comparing Chidamide,Carmustine,Etoposide,Cytarabine and Melphalan With BEAM Regimen Combined With Autologus Hematopoietic Stem Cell Transplantation for the Treatment of Newly Diagnosed PTCL

CSIIT-T29

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.

2023-06-01

2026-02-01

2028-02-01

Recruiting

Early phase I

104

Inclusion Criteria: 1. Pathologically diagnosed patients with newly treated PTCL (including NT/ K-cell lymphoma), except for ALK (+), have CR or PR after first-line treatment; 2. 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. 3. Age between 18 and 65 years old, male and female; 4. ECOG physical strength score 0-1; 5. Neutrophil absolute value ≥1.5×109/L, platelets ≥ 70×109/L, hemoglobin ≥ 90g/L; Number of CD34+ cells ≥ 2.0×106/kg body weight; 6. Expected survival time ≥3 months; 7. Voluntarily sign written informed consent. Exclusion Criteria: 1. Lymphoma involving the central nervous system 2. Active hepatitis B or C virus infection; 3. Active infection; 4. HIV infected persons; 5. Evidence of cirrhosis or liver fibrosis; 6. Ecg showed QTc \> 500ms; 7. Persons with mental disabilities/unable to obtain informed consent; 8. Patients with drug or chronic alcohol abuse that may affect the evaluation of study results; 9. Pregnant and lactating women and women of childbearing age who do not want to take contraceptive measures; 10. The researcher determines that it is not suitable to participate in this study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 104, 'type': 'ESTIMATED'}}

2023-07-05