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

Sponsor
Ou Bai, MD/PHD
Study ID
NCT07493148
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B-Cell Lymphoma (DLBCL)

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Dec 30, 2029
Completion
Dec 30, 2029

Study Design

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

Arms

  • Experimental: Chidamide group
    Chidamide 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.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 24 months ]

Central Contacts

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