Comparing Chi-BEAM and BEAM Regimens for Newly Diagnosed Peripheral T-cell Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the Chi-BEAM regimen with the standard BEAM regimen in patients with newly diagnosed peripheral T-cell lymphoma (PTCL) prior to autologous stem cell transplantation (ASCT). Participants will be randomly assigned to receive either treatment, and the study will evaluate the efficacy and safety of both regimens. The primary endpoint is the two-year progression-free survival (PFS), while secondary endpoints include overall survival (OS), complete response rates, and other safety metrics. This multicenter, randomized controlled trial will provide valuable insights into the best treatment approach for ND PTCL.

Why it matters

Who can join: the full rules

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

Where it's running

• Hematological Department, People's Hospital of Jiangsu Province
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: wei xu — : China, Jiangsu Hematological Department, People's Hospital of Jiangsu Province
• Study coordinator: wei xu
• Email: xuwei10000@hotmail.com
• Phone: 86-25-68302182

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.