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

Recruiting now

Conditions studied: DLBCL

In brief

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

Key facts

Study ID

NCT06779435

Run by

Ruijin Hospital

People needed

400

Starts

2025-01-01

Expected to finish

2028-06-30

Last updated by the study team

2025-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:;
• 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)
• 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.

You may not qualify if…

• 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.

Where it is running

• No. 197 Ruijin 2nd Road, Huangpu District, Shanghai — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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