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

Newly Diagnosed Peripheral T-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05931263
• Other study ID #: CSIIT-T29
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2023
• Est. completion date: February 2028

Study information

• Verified date: June 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: wei xu
• Phone: 86-25-68302182
• Email: xuwei10000[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: February 2028
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma, T-Cell, Peripheral
• Newly Diagnosed Peripheral T-cell Lymphoma

Intervention

Drug:
• C-BEAM Regimen
Chidemide,carmustine, etoposide, cytarabine, and melphalan
• BEAM Regimen
carmustine, etoposide, cytarabine, and melphalan

Locations

Country	Name	City	State
China	Hematological Department, People's Hospital of Jiangsu Province	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-y PFS	2-year PFS	2 years
Secondary	2-year OS		2 years
Secondary	CR rate at 3 months post-transplant evalutation		2 years
Secondary	hematopoietic reconstitution time		2 years
Secondary	Non-recurrent mortality		2 years