Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL

NCT07493148 | Recruiting Phase 2

• 1 other identifier: DLBCL_CRminiCHOP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and safety of chidamide in combination with the R-mini CHOP regimen, followed by chidamide plus CD20 monoclonal antibody as maintenance therapy, in elderly patients with newly diagnosed MYC/BCL2 double-expressor DLBCL.

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Keywords

newly diagnosed MYC/BCL2 double-expressor DLBCL

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first.

  24 months

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  24 months

• Duration of Response (DOR)

  24 months

• Complete Response Rate (CRR)

  24 months

• Percentage of patients converting from PR/SD to CR/PR

  24 months

• Overall survival（OS）

  24 months

Other Outcomes (1)

• Biomarker exploration

  24 months

Study Arms (1)

Chidamide group

EXPERIMENTAL

Chidamide Specification: 5mg / tablet. Induction phase: Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14. 21 days/cycle. R-mini CHOP, Q3W. Maintenance phase: Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14. Rituximab 375 mg/m² IV, once every 12 weeks. 21 days/cycle.

Drug: Chidamide; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Chidamide + Rituximab maintenance

Interventions

Chidamide DRUG

Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14.

Also known as: CS055, HBI-8000, Tucidinostat

Chidamide group

Rituximab DRUG

Rituximab, 375 mg/m² IV, Cycle 1-4, Day 1.

Also known as: MabThera

Chidamide group

Cyclophosphamide DRUG

Cyclophosphamide, 400 mg/m² IV, Cycle 1-4, Day 2.

Also known as: Cytoxan

Chidamide group

Doxorubicin DRUG

Doxorubicin, 25 mg/m² IV, Cycle 1-4, Day 2.

Also known as: Hydroxydaunorubicin

Chidamide group

Vincristine DRUG

Vincristine, 1 mg/m² IV, Cycle 1-4, Day 2.

Also known as: VCR

Chidamide group

Prednisone DRUG

Prednisone, 40 mg/m² orally, Cycle 1-4, Days 1-5.

Chidamide group

Chidamide + Rituximab maintenance DRUG

Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14. Rituximab, 375 mg/m² IV, once every 12 weeks. 21 days/cycle.

Chidamide group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70 years;
• No prior treatment for DLBCL;
• Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): ① Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), and CD20-positive; ② "MYC/BCL2 double-expressor": Immunohistochemistry (IHC) per WHO criteria: MYC ≥ 40%, and BCL2 ≥ 50%; ③ Non-"double-hit" or "triple-hit" lymphoma;
• At least one 18F-fluorodeoxyglucose (18FDG)-avid lesion on positron emission tomography-computed tomography (PET-CT) according to the 2014 Lugano classification for Hodgkin and non-Hodgkin lymphoma;
• International Prognostic Index (IPI) score \> 1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
• At screening, laboratory tests must meet the following criteria, unless judged by the investigator to be due to lymphoma (no corrective or supportive treatment for the indicators below within 2 weeks prior to assessment): ① Hematology: Hemoglobin (Hb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count (PLT) ≥ 90 × 10⁹/L; ② Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis);
• Life expectancy ≥ 6 months;
• Understand and voluntarily sign a written informed consent form.

You may not qualify if:

• Central nervous system (CNS) involvement;
• Transformed lymphoma, i.e., lymphoma transformed from other lymphoma types such as follicular lymphoma, marginal zone B-cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma; specific subtypes of DLBCL (e.g., primary CNS DLBCL, etc.);
• Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases;
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergic reactions to murine products; contraindications to any component of the CHOP regimen or chidamide;
• HIV/HCV infection;
• If HBsAg is positive, HBV DNA testing is required; patients with negative DNA may be enrolled. If HBsAg is negative but HBcAb is positive (regardless of HBsAb status), HBV DNA testing is required; patients with negative DNA may be enrolled.
• Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases;
• Inability to comply with the study protocol due to psychiatric or other unknown reasons;
• For female patients of childbearing potential or male patients with partners of childbearing potential, unwillingness or inability to use effective contraception throughout the study treatment period and for 12 weeks after the last dose of chidamide or 12 months after the last dose of rituximab, whichever is longer; pregnant or breastfeeding women;
• Other conditions deemed unsuitable for participation in this trial.

Sponsors & Collaborators

• Ou Bai, MD/PHD: lead

Study Sites (1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; HBI-8000; Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Ou Bai, PHD

  The First Bethune Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ou Bai, PHD

CONTACT

13039046656; oubai16@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 25, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)