Actively Recruiting

Phase 2
Age: 70Years +
All Genders
NCT07493148

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

Led by Ou Bai, MD/PHD · Updated on 2026-03-25

50

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 70 years or older
  • No prior treatment for diffuse large B-cell lymphoma (DLBCL)
  • Confirmed diagnosis of DLBCL, NOS, with CD20-positive cells
  • MYC expression ≥ 40% and BCL2 expression ≥ 50% by immunohistochemistry
  • Not diagnosed with double-hit or triple-hit lymphoma
  • At least one FDG-avid lesion on PET-CT scan
  • International Prognostic Index (IPI) score greater than 1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Laboratory tests meet specified blood counts and liver/kidney function limits without recent supportive treatment
  • Life expectancy of at least 6 months
  • Able to understand and voluntarily sign informed consent
Not Eligible

You will not qualify if you...

  • Central nervous system involvement
  • Transformed lymphoma from other lymphoma types or specific DLBCL subtypes like primary CNS DLBCL
  • Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infections
  • History of severe allergic or anaphylactic reactions to monoclonal antibodies or sensitivity to murine products
  • Contraindications to any CHOP regimen component or chidamide
  • HIV or hepatitis C infection
  • Positive hepatitis B surface antigen with detectable HBV DNA or inability to confirm negative DNA in certain hepatitis B antibody cases
  • Inability to follow study protocol due to psychiatric or unknown reasons
  • Unwillingness or inability to use effective contraception during treatment and specified post-treatment periods
  • Pregnant or breastfeeding women
  • Other conditions considered unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Bethune Hospital of Jilin University

Changchun, Jilin, China, 130021

Actively Recruiting

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Research Team

O

Ou Bai, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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