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

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.

Study Overview

• Status: Recruiting
• Conditions: Newly Diagnosed Peripheral T-cell Lymphoma
• Intervention / Treatment: Drug: C-BEAM Regimen; Drug: BEAM Regimen

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 Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: WEI XU; Phone Number: 86-25-68302182; Email: xuwei10000@hotmail.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Hematological Department, People's Hospital of Jiangsu Province
      • Contact: Wei Xu, PhD; Phone Number: +86-2568302182; Email: xuwei10000@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-y PFS	2-year PFS	2 years

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Principal Investigator: wei xu, : China, Jiangsu Hematological Department, People's Hospital of Jiangsu Province

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: PTCL; Chidemide
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide; Melphalan; Cytarabine; Carmustine
• Other Study ID Numbers: CSIIT-T29

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No