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

A Multicenter, Phase Ib/II Clinical Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide for Untreated Elderly Diffuse Large B-cell Lymphoma Patients With Double Expression of MYC and BCL2

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Double Expressor DLBCL
• Intervention / Treatment: Drug: Polatuzumab Vedotin; Drug: Rituximab (R); Drug: Chidamide

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qingqing Cai, MD. PhD.; Phone Number: +8602087342823; Email: caiqq@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;
• Age ≥70 years, or age 60-69 years with frailty determined by comprehensive geriatric assessment (CGA).
• Pathologically confirmed diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) with MYC/BCL2 double expression, and no double-hit or triple-hit lymphoma.
• At least one measurable or evaluable lesion according to the Lugano 2014 criteria.
• No prior systemic therapy for DLBCL.
• Adequate organ and bone marrow function.

Exclusion Criteria:

• Other subtypes of DLBCL.
• Lymphoma involvement in the central nervous system or meninges.
• Active infections.
• History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
• Patients with mental disorders or those unable to provide informed consent
• Any other condition deemed by the investigator to be unsuitable for study enrollment.
• Known hypersensitivity to any investigational drug.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLT for Phase 1b	To identify the dose-limiting toxicity	The first cycle after administration (each cycle is 21 days)
RP2D for phase Ib	To identify the recommended phase 2 dose	The first cycle after administration (each cycle is 21 days)
Complete response rate (CRR) for Phase 2	The proportion of patients who achieve complete remission (CR).	Up to 6 cycles (every cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR)	To investigate the preliminary anti-tumor efficacy	Up to 5 years
Progression-free survival (PFS)	To investigate the preliminary anti-tumor efficacy	Up to 5 years
Overall survival (OS)	To investigate the preliminary anti-tumor efficacy	Up to 5 years
Overall response rate (ORR)	The proportion of patients who achieve complete response (CR) or partial response (PR).	Up to 6 cycles (every cycle is 21 days)

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2031

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Rituximab; polatuzumab vedotin; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide
• Other Study ID Numbers: B2025-693

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No