RecruitingPhase 3NCT05931263

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


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

104 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study compares two conditioning regimens (Chi-BEAM vs standard BEAM) used to prepare patients with peripheral T-cell lymphoma (a type of aggressive blood cancer) for an autologous stem cell transplant — where your own stem cells are used to rebuild your immune system after high-dose chemotherapy. **You may be eligible if...** - You have been newly diagnosed with peripheral T-cell lymphoma (excluding certain types) - Your cancer has responded to first-line treatment (complete or partial remission) - You are between 18 and 65 years old - Your heart, lung, kidney, and liver function meet the required levels - You have enough stem cells collected for transplantation - Your general health score (ECOG) is 0 or 1 **You may NOT be eligible if...** - Your lymphoma has spread to the brain or spinal cord - You have active hepatitis B, C, or HIV - You have active infection or cirrhosis - Your heart shows significant electrical abnormalities (QTc over 500ms) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGC-BEAM Regimen

Chidemide,carmustine, etoposide, cytarabine, and melphalan

DRUGBEAM Regimen

carmustine, etoposide, cytarabine, and melphalan


Locations(1)

Hematological Department, People's Hospital of Jiangsu Province

Nanjing, Jiangsu, China

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NCT05931263