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

NCT ID: NCT06779435

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2028-06-30

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.

Conditions

DLBCL

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Low intensity treatment options

Intervention Type: 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 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.

Conventional immunochemotherapy regimen

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Pengpeng Xu, professor

Role: CONTACT

pengpeng_xu@126.com

13564015001

Facility Contacts

Pengpeng Xu

Role: primary

pengpeng_xu@126.com

13564015001

Other Identifiers

CSIIT-B42

Identifier Type: -

Identifier Source: org_study_id