Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission

Sponsor
Rong Tao
Study ID
NCT07507318
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Chidamide — DRUG
    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.

Study Details

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.

Key Dates

First listed
Apr 2, 2026
Start date
Jun 16, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
69 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

ctDNA MRD Negativity Rate [ Time Frame: From first dose up to 24 months ]

Central Contacts

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