A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of DLBCL

Shanghai Jiao Tong University

Status: Enrolling

Conditions: DLBCL

Treatments: Drug: Conventional immunochemotherapy regimen; Drug: Low intensity treatment options

Study type: Observational

Funder types: Other

Identifiers

NCT06779435

CSIIT-B42

Details and patient eligibility

About

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

Full description

The study was divided into 2 cohorts. 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. Reference options for a combination regimen include C-R2, C-R-mini-CHOP, etc.

Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit. Reference options for a combination regimen include CR-CHOP, C-Pola-R-CHP, etc.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:;

  4. 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)

  5. 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.

Trial design

400 participants in 2 patient groups

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.

Treatment:

Drug: Low intensity treatment options

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.

Treatment:

Drug: Conventional immunochemotherapy regimen