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

RecruitingPhase 3Ages 18 Years - 65 YearsAllThe First Affiliated Hospital with Nanjing Medica…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • C-BEAM Regimen
  • BEAM Regimen
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Where

1 site
Hematological Department, People's Hospital of Jiangsu Province
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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