Phase Ib/II Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide in Newly Diagnosed Elderly Patients With Double-Expressor DLBCL

Sponsor
Sun Yat-sen University
Study ID
NCT07415980
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Double Expressor DLBCL

Eligibility Criteria

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

Interventions

  • Polatuzumab Vedotin — DRUG
    1.8 mg/kg intravenously on Day 1 of each 21-day cycle.
  • Rituximab (R) — DRUG
    375 mg/m² intravenously once weekly during Cycle 1, followed by administration on Day 1 of each subsequent cycle.
  • Chidamide — DRUG
    20 mg, po, biw

Study Details

This is a single-arm, prospective, multicenter, open-label phase Ib/II study to evaluate the safety and efficacy of polatuzumab vedotin in combination with rituximab and chidamide in previously untreated elderly patients with MYC/BCL2 double-expressor diffuse large B-cell lymphoma.

Key Dates

Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2031

Study Design

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

Arms

  • Experimental: Polatuzumab Vedotin in Combination With Rituximab and Chidamide
    Participants receive polatuzumab vedotin in combination with rituximab and chidamide. Polatuzumab vedotin and rituximab are administered intravenously on Day 1 of each 21-day cycle according to the protocol-specified schedule. Chidamide is administered orally twice weekly, with an initial dose of 20 mg from Day 1 to Day 14, and at the RP2D dose level in the extension phase. Combination therapy is given for up to six cycles. Patients achieving complete response after combination therapy may receive chidamide monotherapy as maintenance treatment according to the study protocol.

Primary Outcome Measure

DLT for Phase 1b [ Time Frame: The first cycle after administration (each cycle is 21 days) ]

Central Contacts

Related Studies