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

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

Study Overview

• Status: Recruiting
• Conditions: DLBCL
• Intervention / Treatment: Drug: Low intensity treatment options; Drug: Conventional immunochemotherapy regimen

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Pengpeng Xu, professor; Phone Number: 13564015001; Email: pengpeng_xu@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • No. 197 Ruijin 2nd Road, Huangpu District, Shanghai
      • Contact: Pengpeng Xu; Phone Number: 13564015001; Email: pengpeng_xu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

400

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Low intensity treatment options; Reference options for a combined regimen include C-R2, C-R-mini-CHOP, etc. Subjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. .Single-drug maintenance is recommended to last 24 weeks
Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit.	Drug: Conventional immunochemotherapy regimen; Reference options for a combined regimen include CR-CHOP, C-Pola-R-CHP, etc. Subjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. Single-drug maintenance is recommended to last 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EFS（Event-free survival）	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.	2-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRR（Complete response rate）	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.	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
PFS（Progression-free survival）	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	2-year
OS（Overall survival）	From the start of treatment to the time of death from any cause.	2-year

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: January 11, 2025
• First Submitted That Met QC Criteria: January 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: DLBCL; Tucidinostat
• Other Study ID Numbers: CSIIT-B42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No