Clinical trial NCT06779435: A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of DLBCL
Official title: A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of Diffuse Large B-cell Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: DLBCL
Keywords: Tucidinostat
DLBCL
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 400

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

Detailed 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.

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.

Primary outcomes:
measure: EFS（Event-free survival）
timeFrame: 2-year
Secondary outcomes:
measure: CRR（Complete response rate）
timeFrame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
measure: PFS（Progression-free survival）
timeFrame: 2-year
measure: OS（Overall survival）
timeFrame: 2-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: No. 197 Ruijin 2nd Road, Huangpu District, Shanghai
state: Shanghai
Study officials:
References: