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Recruiting NCT05931263

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

Phase III Interventional Newly Diagnosed Peripheral T-cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: C-BEAM Regimen, BEAM Regimen.
Who it may be relevant to
Registry conditions: Newly Diagnosed Peripheral T-cell Lymphoma. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

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

Primary outcome measures

  • 2-y PFS [Time frame: 2 years]
Secondary outcome measures (4)
  • 2-year OS [Time frame: 2 years]
  • CR rate at 3 months post-transplant evalutation [Time frame: 2 years]
  • hematopoietic reconstitution time [Time frame: 2 years]
  • Non-recurrent mortality [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Hematological Department, People's Hospital of Jiangsu Province — Nanjing

Identifiers

NCT: NCT05931263 · CSIIT-T29

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗