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RecruitingNCT07493148Updated Mar 25, 2026

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

A Phase 2 interventional study of Chidamide and Rituximab in Diffuse Large B-Cell Lymphoma (DLBCL), sponsored by Ou Bai, MD/PHD. Recruiting at 1 site in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-03-25.

Sponsored by Ou Bai, MD/PHD · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
70 Years and older
Sex
All
01

Study 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.

Read the detailed description

The primary study objective is to evaluate the 2-year progression-free survival (PFS) rate of chidamide in combination with the R-miniCHOP regimen. Secondary objectives include the objective response rate (ORR), duration of response (DOR), complete response (CR) rate, the percentage of patients converting from PR/SD to CR/PR, overall survival (OS), and safety parameters. The exploratory objective is to investigate the correlation between biomarkers (e.g., tumor genomics, proteomics) and ctDNA with treatment efficacy.

02

Conditions studied

  • Diffuse Large B-Cell Lymphoma (DLBCL)

Keywords

  • newly diagnosed MYC/BCL2 double-expressor DLBCL
03

In context

Lymphoma, Large B-Cell, Diffuse

1,389 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 349 are open to participants now.

This study's planned enrollment of 50 is close to the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

Ou Bai, MD/PHD is the lead sponsor of 7 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 70 years;
  2. No prior treatment for DLBCL;
  3. 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;
  4. 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;
  5. International Prognostic Index (IPI) score > 1;
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
  7. 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);
  8. Life expectancy ≥ 6 months;
  9. Understand and voluntarily sign a written informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Central nervous system (CNS) involvement;
  2. 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.);
  3. Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases;
  4. 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;
  5. HIV/HCV infection;
  6. 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.
  7. Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases;
  8. Inability to comply with the study protocol due to psychiatric or other unknown reasons;
  9. 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;
  10. Other conditions deemed unsuitable for participation in this trial.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Chidamide group

    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

  • DrugChidamide

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

    Also known as: CS055, HBI-8000, Tucidinostat

  • DrugRituximab

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

    Also known as: MabThera

  • DrugCyclophosphamide

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

    Also known as: Cytoxan

  • DrugDoxorubicin

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

    Also known as: Hydroxydaunorubicin

  • DrugVincristine

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

    Also known as: VCR

  • DrugPrednisone

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

  • DrugChidamide + Rituximab maintenance

    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.

06

What researchers measure

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.

    Time frame: 24 months

Secondary outcomes

  1. Overall Response Rate (ORR)

    To assess the Overall Response Rate (ORR) referred to Lugano 2014.

    Time frame: 24 months

  2. Duration of Response (DOR)

    The duration from the first documentation of response (achievement of complete response or partial response) to the first unequivocal evidence of relapse or progression.

    Time frame: 24 months

  3. Complete Response Rate (CRR)

    To assess the Complete Response Rate (CRR) referred to Lugano 2014.

    Time frame: 24 months

  4. Percentage of patients converting from PR/SD to CR/PR

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

    Time frame: 24 months

  5. Overall survival（OS）

    Overall survival（OS） is defined as the time from the date of enrollment to the date of death from any cause.

    Time frame: 24 months

  6. Adverse Events

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment, assessed by NCI-CTCAE v5.0. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Time frame: 24 months

Other outcomes

  1. Biomarker exploration

    ctDNA testing will be performed at baseline, after 6 cycles of treatment, every 6 months during the maintenance period, and at disease progression or study withdrawal, to evaluate the correlation between ctDNA and treatment efficacy.

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • The First Bethune Hospital of Jilin University
    Changchun, Jilin 130021, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07493148
Lead sponsor
Ou Bai, MD/PHD
Responsible party
Ou Bai, MD/PHD (Director, The First Hospital of Jilin University) — Sponsor-investigator
First posted
Mar 25, 2026
Start date
Apr 30, 2026 (estimated)
Primary completion
Dec 30, 2029 (estimated)
Completion
Dec 30, 2029 (estimated)
Last update
Mar 25, 2026

Study contacts

Ou Bai, PHD
Contact
oubai16@163.com
13039046656
Ou Bai, PHD
principal investigator · The First Bethune Hospital of Jilin University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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