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

NCT06779435 | Recruiting

• 1 other identifier: CSIIT-B42
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

DLBCL

Keywords

Tucidinostat; DLBCL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• CRR（Complete response rate）

  End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

• PFS（Progression-free survival）

  2-year

• OS（Overall survival）

  2-year

Study Arms (2)

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

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.

Drug: Conventional immunochemotherapy regimen

Interventions

Low intensity treatment options DRUG

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 1: DLBCL patients diagnosed unfit/ Unfit.

Conventional immunochemotherapy regimen DRUG

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

Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

400

You may qualify if:

• \. Age ≥18 years old, male or female;
• \. No previous treatment for DLBCL, including chemotherapy, targeted therapy and immunotherapy;
• \. 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
• \. 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);
• \. Voluntarily sign informed consent.

You may not qualify if:

• \. Patients currently enrolled or planning to participate in any interventional clinical trial;
• \. The expected survival time is less than 6 months;
• \. There are any other reasons that the investigators believe are not suitable for patients to participate in this study.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

No. 197 Ruijin 2nd Road, Huangpu District, Shanghai

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Pengpeng Xu, professor

CONTACT

13564015001; pengpeng_xu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: January 16, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)