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RecruitingNCT05931263Updated Jul 5, 2023

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

A Phase 3 interventional study of C-BEAM Regimen and BEAM Regimen in Newly Diagnosed Peripheral T-cell Lymphoma, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-05.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Newly Diagnosed Peripheral T-cell Lymphoma

Keywords

  • PTCL
  • Chidemide
03

In context

Lymphoma, T-Cell, Peripheral

604 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 133 are open to participants now.

This study's planned enrollment of 104 is above the median of 38 across 526 interventional studies indexed under Lymphoma, T-Cell, Peripheral.

Browse Lymphoma, T-Cell, Peripheral studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    C-BEAM

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

    Drug: C-BEAM Regimen

  • Sham comparator
    BEAM

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

    Drug: BEAM Regimen

Interventions

  • DrugC-BEAM Regimen

    Chidemide,carmustine, etoposide, cytarabine, and melphalan

  • DrugBEAM Regimen

    carmustine, etoposide, cytarabine, and melphalan

06

What researchers measure

Primary outcomes

  1. 2-y PFS

    2-year PFS

    Time frame: 2 years

Secondary outcomes

  1. 2-year OS

    Time frame: 2 years

  2. CR rate at 3 months post-transplant evalutation

    Time frame: 2 years

  3. hematopoietic reconstitution time

    Time frame: 2 years

  4. Non-recurrent mortality

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Hematological Department, People's Hospital of Jiangsu Province
    Nanjing, Jiangsu 210029, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05931263
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Jul 5, 2023
Start date
Jun 1, 2023
Primary completion
Feb 2026 (estimated)
Completion
Feb 2028 (estimated)
Last update
Jul 5, 2023

Study contacts

wei xu
Contact
xuwei10000@hotmail.com
86-25-68302182
wei xu
principal investigator · : China, Jiangsu Hematological Department, People's Hospital of Jiangsu Province

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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