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

ConditionDiffuse Large B-Cell Lymphoma (DLBCL)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age70+

SponsorOu Bai, MD/PHD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

Chidamide
Drug
Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14.
Rituximab
Drug
Rituximab, 375 mg/m² IV, Cycle 1-4, Day 1.
Cyclophosphamide
Drug
Cyclophosphamide, 400 mg/m² IV, Cycle 1-4, Day 2.
Doxorubicin
Drug
Doxorubicin, 25 mg/m² IV, Cycle 1-4, Day 2.
Vincristine
Drug
Vincristine, 1 mg/m² IV, Cycle 1-4, Day 2.
Prednisone
Drug
Prednisone, 40 mg/m² orally, Cycle 1-4, Days 1-5.
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.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Chidamide groupExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

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

Overall Response Rate (ORR)

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

Time frame

24 months

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

Complete Response Rate (CRR)

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

Time frame

24 months

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

Time frame

24 months

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ou Bai, MD/PHD

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov

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