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

NCT07415980 | Not Yet Recruiting Phase 1

• 1 other identifier: B2025-693
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Double Expressor DLBCL

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Overall response rate (ORR)

  Up to 6 cycles (every cycle is 21 days)

• Duration of Response (DOR)

  Up to 5 years

• Progression-free survival (PFS)

  Up to 5 years

• Overall survival (OS)

  Up to 5 years

Study Arms (1)

Polatuzumab Vedotin in Combination With Rituximab and Chidamide

EXPERIMENTAL

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; Drug: Rituximab (R); Drug: Chidamide

Interventions

Polatuzumab Vedotin DRUG

1.8 mg/kg intravenously on Day 1 of each 21-day cycle.

Polatuzumab Vedotin in Combination With Rituximab and Chidamide

Rituximab (R) DRUG

375 mg/m² intravenously once weekly during Cycle 1, followed by administration on Day 1 of each subsequent cycle.

Polatuzumab Vedotin in Combination With Rituximab and Chidamide

Chidamide DRUG

20 mg, po, biw

Polatuzumab Vedotin in Combination With Rituximab and Chidamide

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Interventions

polatuzumab vedotin; Rituximab; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Qingqing Cai, MD. PhD.

CONTACT

+8602087342823; caiqq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2031
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share