Clinical trial · Observational
A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of DLBCL
A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of Diffuse Large B-cell Lymphoma
NCT06779435CI-TRIAL-00086190recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional immunochemotherapy regimen | Drug | — | UNRESOLVED |
| Low intensity treatment options | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1: DLBCL patients diagnosed unfit/ Unfit.
- description
- A person who is unfit/ unfit is defined as being 80 years or older, or younger than 80 years old but has comorbidities and cannot tolerate a standard dose of chemotherapy as determined by the investigator.
- interventionNames
- Drug: Low intensity treatment options
- label
- Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit.
- description
- Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit.
- interventionNames
- Drug: Conventional immunochemotherapy regimen
Primary outcomes (1)
- measure
- EFS（Event-free survival）
- timeFrame
- 2-year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.