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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05931263

Enrollment

104

Registered

2023-07-05

Start date

2023-06-01

Completion date

2028-02-29

Last updated

2023-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed Peripheral T-cell Lymphoma

Keywords

PTCL, Chidemide

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)

Interventions

DRUGC-BEAM Regimen

Chidemide，carmustine, etoposide, cytarabine, and melphalan

DRUGBEAM Regimen

carmustine, etoposide, cytarabine, and melphalan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
2-y PFS	2 years	2-year PFS

Secondary

Measure	Time frame
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

Countries

China

Contacts

Primary Contactwei xu

xuwei10000@hotmail.com86-25-68302182

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026