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

Recruiting

• Conditions: DLBCL
• Interventions: Drug: Low intensity treatment options; Drug: Conventional immunochemotherapy regimen

• Registration Number: NCT06779435
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study Start: 2025-01-01
• Study First Submitted: 2025-01-11
• Study First Submitted QC: 2025-01-11
• Study First Posted: 2025-01-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1: DLBCL patients diagnosed unfit/ Unfit.	Low intensity treatment options	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.	Conventional immunochemotherapy regimen	Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit.

Primary Outcome Measures

Name	Time	Method
EFS（Event-free survival）	2-year	The length of time from the start of treatment to the onset of disease progression, recurrence after CR, death from any cause, or the start of new therapy for residual lesions (including conversion therapy for lesions during the trial) after the end of combination therapy, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
CRR（Complete response rate）	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]	The number of subjects who achieved complete response (CR) at the end of combination therapy as a percentage of the total number of participants in the analysis.
PFS（Progression-free survival）	2-year	The length of time from the start of treatment to the onset of disease progression or recurrence or death from any cause, whichever occurs first
OS（Overall survival）	2-year	From the start of treatment to the time of death from any cause.

Trial Locations

Locations (1)

No. 197 Ruijin 2nd Road, Huangpu District, Shanghai; 🇨🇳 Shanghai, Shanghai, China