Evaluating tucidinostat for treating newly diagnosed DLBCL patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, observational study aims to assess the clinical efficacy and safety of tucidinostat in the real-world treatment of primary diffuse large B-cell lymphoma (DLBCL) among 400 newly treated patients. The study is divided into two cohorts: one for patients deemed unfit for standard chemotherapy and another for those who are fit. Patients will receive low-intensity treatment options or conventional immunochemotherapy regimens based on their cohort classification. The study will gather data on treatment outcomes and patient responses to inform future therapeutic strategies.

Why it matters

Who can join: the full rules

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.

Where it's running

• No. 197 Ruijin 2nd Road, Huangpu District, Shanghai
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Pengpeng Xu, professor
• Email: pengpeng_xu@126.com
• Phone: 13564015001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.