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

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

This study is testing whether a new treatment called Chi-BEAM works better than the standard BEAM treatment for people with newly diagnosed peripheral T-cell lymphoma before they have a stem cell transplant.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05931263 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 to 65 with newly diagnosed PTCL who have achieved a complete or partial response after first-line treatment.

Not a fit: Patients with central nervous system involvement or active hepatitis B or C virus infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to improved survival rates for patients with newly diagnosed PTCL.

How similar studies have performed: Previous studies have shown promising results with similar treatment regimens, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

• 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

Conditions Newly Diagnosed Peripheral T-cell Lymphoma; PTCL; Chidemide