NCT06779435 A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of DLBCL
| NCT ID | NCT06779435 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | DLBCL |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-12-31 |
Trial Parameters
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Brief 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 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 interve