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AzTrials

Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2NCT07493148

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

A Phase 2 study testing Chidamide, Rituximab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Ou Bai, MD/PHD at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma (DLBCL)
What is being tested?
Chidamide, Rituximab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
30 Apr 2026to 30 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ou Bai, PHD contact

13039046656

oubai16@163.com

China1 site, 1 recruiting

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

    Ou Bai, PHD, 13039046656, oubai16@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase II, Open-label, Single-arm Clinical Study of Chidamide in Combination With the R-mini CHOP Regimen, Followed by Chidamide Plus CD20 as Maintenance Therapy, in Elderly Patients With Newly Diagnosed MYC/BCL2 Co-expressor DLBCL

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.

Keywords
newly diagnosed MYC/BCL2 double-expressor DLBCL
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChidamideDrug

    Also called CS055, HBI-8000, Tucidinostat

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

  • RituximabDrug

    Also called MabThera

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

  • CyclophosphamideDrug

    Also called Cytoxan

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

  • DoxorubicinDrug

    Also called Hydroxydaunorubicin

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

  • VincristineDrug

    Also called VCR

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

  • PrednisoneDrug

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

  • Chidamide + Rituximab maintenanceDrug

    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.

Study groups in NCT07493148
Study groupRoleWhat they receive
Chidamide groupExperimentalChidamide 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.
Receives: Drug: Chidamide; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Chidamide + Rituximab maintenance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

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

    Measured: 24 months

Secondary outcomes (6)

  1. Overall Response Rate (ORR)

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

    Measured: 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.

    Measured: 24 months

  3. Complete Response Rate (CRR)

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

    Measured: 24 months

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

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

    Measured: 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.

    Measured: 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start30 Apr 2026 (estimated)
  3. Primary completion30 Dec 2029 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07493148
Sponsor's protocol ID
DLBCL_CRminiCHOP
Status last verified
Mar 2026
First submitted
20 Mar 2026
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chidamide, Rituximab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Ou Bai, MD/PHD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ou Bai, PHD (13039046656, oubai16@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07493148.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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