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

Phase 3

Recruiting

• Conditions: Newly Diagnosed Peripheral T-cell Lymphoma
• Interventions: Drug: BEAM Regimen; Drug: C-BEAM Regimen

• Registration Number: NCT05931263
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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.

Detailed Description

This is a prospective, multicenter, randomized controlled, open trial. The primary endpoint was 2-year PFS The secondary endpoint was： 2-year overall survival (OS). CR rate at 3 months post-transplant evaluation Hematopoietic reconstitution time Non-recurrent mortality (NRM)

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-01
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Last Update Submitted: 2023-06-27
• Study First Posted: 2023-07-05
• Last Update Posted: 2023-07-05
• Primary Completion: 2026-02
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BEAM	BEAM Regimen	carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation
C-BEAM	C-BEAM Regimen	Chidemide，carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation

Primary Outcome Measures

Name	Time	Method
2-y PFS	2 years	2-year PFS

Secondary Outcome Measures

Name	Time	Method
2-year OS	2 years
CR rate at 3 months post-transplant evalutation	2 years
hematopoietic reconstitution time	2 years
Non-recurrent mortality	2 years

Trial Locations

Locations (1)

Hematological Department, People's Hospital of Jiangsu Province; 🇨🇳 Nanjing, Jiangsu, China