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

Ruijin Hospital400 enrolled

Overview

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

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

400

Conditions

DLBCL

Interventions

Low intensity treatment optionsDRUG

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

Conventional immunochemotherapy regimenDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 2-year

Secondary Outcomes

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.

Time frame: 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

Time frame: 2-year

OS（Overall survival）

From the start of treatment to the time of death from any cause.

Time frame: 2-year

Central Contacts

Pengpeng Xu, professor

CONTACT

13564015001 pengpeng_xu@126.com

Data from ClinicalTrials.gov

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