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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
No. 197 Ruijin 2nd Road, Huangpu District, Shanghai
RECRUITING
Shanghai
Contact Information
Primary
Pengpeng Xu, professor
pengpeng_xu@126.com
13564015001
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 400
Treatments
Cohort 1: DLBCL patients diagnosed unfit/ Unfit.
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.
Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit.
Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit.
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov