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

Launched by RUIJIN HOSPITAL · Jan 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called tucidinostat for patients with a type of cancer known as diffuse large B-cell lymphoma (DLBCL). The goal is to see how effective and safe this treatment is when used in real-world settings with patients who are newly diagnosed and have not received any prior treatment for their cancer. The trial is looking for about 400 participants aged 18 and older who have specific characteristics in their cancer cells, which have been confirmed by a medical test.

To be eligible for the study, patients must be starting treatment for DLBCL, and they need to have certain genetic features in their cancer cells. Participants will receive a treatment plan that includes tucidinostat and will be closely monitored by doctors throughout the study. It’s important to know that patients currently involved in other clinical trials or those with a very short expected survival time may not qualify for this study. If you or a loved one are considering participating, you would need to sign a consent form to agree to join the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years old, male or female;
• • 2. No previous treatment for DLBCL, including chemotherapy, targeted therapy and immunotherapy;
• • 3. DEL \[Diffuse large B-cell lymphoma with double expression of MYC and BCL2 (immunohistochemical MYC≥40%, BCL2≥50%)\] was confirmed by pathology; Or non-double expression but at least one of the following:;
• • 1. TP53 or other epigenetic gene mutations (as in: ACTB, BCL6, BCOR, CREBBP, EP300, EZH2, HIST1H1C, HIST1H1E, HIST1H2BK, HIST2H2AB, IRF4, KMT2A, KMT2C, KMT2D, MYC, MYD88, NSD2, RAG1, SETD1B SF3B1, SIN3A, TBL1XR1, TET2, TOX, TP53, TRIP12, TRRAP, UBE2A)
• • 2. MYC and BCL2 double hit
• • 4. Plan to receive or are receiving a treatment regimen containing tucidinostat (if it is permitted to start using tucidinostat after obtaining specific test results due to pending genetic sequencing results);
• • 5. Voluntarily sign informed consent.
• Exclusion Criteria:
• • 1. Patients currently enrolled or planning to participate in any interventional clinical trial;
• • 2. The expected survival time is less than 6 months;
• • 3. There are any other reasons that the investigators believe are not suitable for patients to participate in this study.