RecruitingNCT06779435

A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of DLBCL

A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of Diffuse Large B-cell Lymphoma


Sponsor

Ruijin Hospital

Enrollment

400 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This is a prospective, observational, multicenter, cohort study with 400 newly treated DLBCL patients. To evaluate the clinical efficacy and safety of tucidinostat in the real-world treatment of primary diffuse large B-cell lymphoma


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world data on patients with a type of aggressive lymphoma called diffuse large B-cell lymphoma (DLBCL) who are receiving a treatment regimen that includes a drug called tucidinostat. Researchers specifically want to study patients with high-risk subtypes of this cancer to see how well this approach works in practice. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with DLBCL and have not yet received any treatment for it - Your tumor has a high-risk feature such as double expression of MYC and BCL2 proteins, or specific genetic mutations (like TP53), or a MYC/BCL2 double hit - You are planned to receive or are currently receiving a treatment regimen that includes tucidinostat **You may NOT be eligible if...** - You have already received chemotherapy or other treatments for DLBCL - Your tumor does not have the high-risk features required by the study - You have serious organ function problems that would prevent safe treatment 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

DRUGLow intensity treatment options

Reference options for a combined regimen include C-R2, C-R-mini-CHOP, etc. Subjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. .Single-drug maintenance is recommended to last 24 weeks

DRUGConventional immunochemotherapy regimen

Reference options for a combined regimen include CR-CHOP, C-Pola-R-CHP, etc. Subjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. Single-drug maintenance is recommended to last 24 weeks


Locations(1)

No. 197 Ruijin 2nd Road, Huangpu District, Shanghai

Shanghai, Shanghai Municipality, China

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NCT06779435


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