Evaluating tucidinostat for treating newly diagnosed DLBCL patients

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

This study is testing if a new drug called tucidinostat can help newly diagnosed patients with diffuse large B-cell lymphoma feel better and stay safe, comparing results between those who can and can't handle standard chemotherapy.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06779435 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed DLBCL who have not received prior treatment.

Not a fit: Patients currently enrolled in other interventional studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with DLBCL who are unable to tolerate standard chemotherapy.

How similar studies have performed: While there have been studies on DLBCL treatments, the specific use of tucidinostat in this context is novel and has not been extensively tested.

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.

Where this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Pengpeng Xu, professor

Conditions DLBCL; Tucidinostat