NCT06779435Recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 11 Jan 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Ruijin Hospital
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT06779435
What you commit to
- Study type: Observational
- Planned participants: 400
- From 1 Jan 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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:;
- 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)
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| No. 197 Ruijin 2nd Road, Huangpu District, Shanghai Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.