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

Recruiting now · Phase 3

Conditions studied: Newly Diagnosed Peripheral T-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT05931263

Run by

The First Affiliated Hospital with Nanjing Medical University

People needed

104

Starts

2023-06-01

Expected to finish

2028-02-01

Last updated by the study team

2023-07-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Hematological Department, People's Hospital of Jiangsu Province — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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