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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05931263

Collaborator

(none)

104

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Newly Diagnosed Peripheral T-cell Lymphoma	Drug: C-BEAM Regimen Drug: BEAM Regimen	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2026

Anticipated Study Completion Date :

Feb 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: C-BEAM Chidemide，carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation	Drug: C-BEAM Regimen Chidemide，carmustine, etoposide, cytarabine, and melphalan
Sham Comparator: BEAM carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation	Drug: BEAM Regimen carmustine, etoposide, cytarabine, and melphalan

Arm

Intervention/Treatment

Experimental: C-BEAM

Chidemide，carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation

Drug: C-BEAM Regimen

Chidemide，carmustine, etoposide, cytarabine, and melphalan

Sham Comparator: BEAM

carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation

Drug: BEAM Regimen

carmustine, etoposide, cytarabine, and melphalan

Outcome Measures

Primary Outcome Measures

2-y PFS [2 years]
2-year PFS

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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