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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2025-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06779435 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying DLBCL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06779435 currently recruiting?
Yes, NCT06779435 is actively recruiting participants. Contact the research team at pengpeng_xu@126.com for enrollment information.
Where is the NCT06779435 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06779435 clinical trial?
NCT06779435 is sponsored by Ruijin Hospital. The trial plans to enroll 400 participants.