Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission (DEL-MRD-CHID)

March 27, 2026 updated by: Rong Tao

A Prospective, Multicenter, Single-Arm, Open-Label Phase 2 Study of Chidamide Maintenance in Patients With Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma Who Achieve Complete Response After Induction Therapy But Remain ctDNA MRD-Positive

This is a prospective, multicenter, single-arm, open-label phase 2 study designed to evaluate the efficacy and safety of chidamide maintenance in adults with newly diagnosed double-expressor diffuse large B-cell lymphoma (DLBCL) who achieve complete response after induction therapy but remain ctDNA minimal residual disease (MRD)-positive. Eligible participants will receive oral chidamide 20 mg on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD will be assessed every 12 weeks. Treatment will continue until two consecutive MRD-negative assessments, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance. The primary objectives are to evaluate ctDNA MRD negativity and 2-year progression-free survival. Secondary objectives include event-free survival, overall survival, and safety.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with double-expressor DLBCL remain at increased risk of relapse despite achieving complete response after induction therapy. ctDNA-based MRD assessment may identify a subgroup with persistent molecular disease who are at particularly high risk for recurrence. Chidamide is an oral selective histone deacetylase inhibitor with potential antitumor and immune-modulating activity in B-cell lymphomas.

This prospective, multicenter, single-arm, open-label phase 2 study will enroll adult patients with newly diagnosed CD20-positive double-expressor DLBCL, defined by MYC expression >=40% and BCL2 expression >=50% by immunohistochemistry, who achieve complete response after initial induction therapy but remain ctDNA MRD-positive. Participants will receive chidamide 20 mg orally on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD will be monitored every 12 weeks. Treatment will stop upon two consecutive MRD-negative assessments, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance. The study will evaluate ctDNA MRD negativity rate and 2-year progression-free survival as primary endpoints, with event-free survival, overall survival, and safety as secondary endpoints.

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rong Tao, MD & PhD
  • Phone Number: 008621-64175590
  • Email: rao@shca.org.cn

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 20000
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed diffuse large B-cell lymphoma, CD20-positive.
  • Double-expressor lymphoma confirmed by pathology, defined as MYC expression >=40% and BCL2 expression >=50% by immunohistochemistry.
  • Complete response after initial induction therapy.
  • Age >=18 and <=80 years.
  • ECOG performance status 0-2.
  • No prior history of malignant tumor and no concurrent malignancy.
  • International Prognostic Index (IPI) score >1.
  • ctDNA MRD-positive at screening/enrollment.
  • Life expectancy of at least 6 months, in the opinion of the investigator.
  • Written informed consent provided before any study-specific procedure.

Exclusion Criteria:

  • Failure to achieve complete response after initial induction therapy.
  • Prior organ transplantation.
  • Uncontrolled coagulopathy or active bleeding.
  • Uncontrolled cardiovascular or cerebrovascular disease, including left ventricular ejection fraction <50%, connective tissue disease, or severe active infection.
  • Major organ surgery within 6 weeks before screening.
  • Screening laboratory abnormalities not attributable to lymphoma, including: neutrophil count <1.5 x 10^9/L; platelet count <80 x 10^9/L (or <50 x 10^9/L in patients with bone marrow involvement); total bilirubin >1.5 x upper limit of normal; ALT/AST >2.5 x upper limit of normal, or >5 x upper limit of normal in patients with hepatic involvement; serum creatinine >1.5 x upper limit of normal.
  • Active hepatitis B not meeting protocol-defined virologic criteria for enrollment; patients with positive HBsAg or positive HBcAb require HBV DNA testing and must meet protocol-specified thresholds.
  • HIV infection.
  • Ongoing antitumor therapy for lymphoma or another malignancy.
  • Drug abuse or chronic alcohol abuse that may interfere with study evaluation.
  • Psychiatric illness or any condition resulting in inability to comply with the protocol.
  • Requirement for ongoing treatment with strong or moderate CYP3A inhibitors or inducers; patients exposed to these agents within 7 days before first study dose, or within fewer than 5 half-lives, are not eligible.
  • Inability to swallow capsules or clinically significant gastrointestinal disorders that may affect drug absorption, including malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial/complete bowel obstruction.
  • Any other uncontrolled medical condition that, in the investigator's judgment, may compromise safety, interfere with oral drug absorption or metabolism, or place the participant at excessive risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chidamide Maintenance
Participants with newly diagnosed double-expressor DLBCL who achieve complete response after induction therapy but remain ctDNA MRD-positive will receive chidamide maintenance therapy.
Drug: Chidamide
Chidamide 20 mg orally on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD assessments will be performed every 12 weeks. Treatment will continue until two consecutive MRD-negative assessments at least 3 months apart, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ctDNA MRD Negativity Rate
Time Frame: From first dose up to 24 months
The proportion of enrolled participants who convert from ctDNA MRD-positive status at study entry to ctDNA MRD-negative status during chidamide maintenance, based on the protocol-specified ctDNA assay.
From first dose up to 24 months
2-Year Progression-Free Survival Rate
Time Frame: 24 months after study entry
The proportion of enrolled participants who are alive and free of disease progression 24 months after study entry.
24 months after study entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-Free Survival
Time Frame: From study entry up to 24 months
Time from study entry to disease progression, initiation of new antitumor therapy, or death from any cause.
From study entry up to 24 months
Overall Survival
Time Frame: From study entry up to 24 months
Time from study entry to death from any cause.
From study entry up to 24 months
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Time Frame: From first dose to 30 days after last dose.
Incidence of hematologic and non-hematologic adverse events and serious adverse events, graded according to NCI CTCAE version 5.0.
From first dose to 30 days after last dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rong Tao

Investigators

  • Study Chair: Rong Tao, MD & PhD, Fudan University
  • Principal Investigator: Wenhao Zhang, MD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEL-MRD-CHID-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A decision regarding sharing de-identified individual participant data has not yet been made. This is an investigator-initiated, multicenter study involving ctDNA MRD-related data, and the sponsor has not yet finalized the data-sharing governance, de-identification standards, request review process, and applicable data-sharing agreements across participating sites. The possibility of sharing de-identified data may be considered after study completion and database lock, in accordance with participant consent, ethics committee requirements, institutional policies, and applicable regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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