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

NCT05931263 | Recruiting Phase 3

• 1 other identifier: CSIIT-T29
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Newly Diagnosed Peripheral T-cell Lymphoma

Keywords

PTCL; Chidemide

Outcome Measures

Primary Outcomes (1)

• 2-y PFS

  2-year PFS

  2 years

Secondary Outcomes (4)

• 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

Study Arms (2)

C-BEAM

EXPERIMENTAL

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

Drug: C-BEAM Regimen

BEAM

SHAM COMPARATOR

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

Drug: BEAM Regimen

Interventions

C-BEAM Regimen DRUG

Chidemide，carmustine, etoposide, cytarabine, and melphalan

C-BEAM

BEAM Regimen DRUG

carmustine, etoposide, cytarabine, and melphalan

BEAM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Hematological Department, People's Hospital of Jiangsu Province

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Interventions

BEAM regimen

Study Officials

• wei xu

  : China, Jiangsu Hematological Department, People's Hospital of Jiangsu Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wei xu

CONTACT

86-25-68302182; xuwei10000@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 5, 2023
• Study Start: June 1, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 5, 2023

Record last verified: 2023-06

Locations

CN (1)