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NCT Number: NCT07415980

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

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.

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Key information

Conditions

Double Expressor DLBCL

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. DLT for Phase 1b

    Time frame: The first cycle after administration (each cycle is 21 days)

    To identify the dose-limiting toxicity

  2. RP2D for phase Ib

    Time frame: The first cycle after administration (each cycle is 21 days)

    To identify the recommended phase 2 dose

  3. Complete response rate (CRR) for Phase 2

    Time frame: Up to 6 cycles (every cycle is 21 days)

    The proportion of patients who achieve complete remission (CR).

Secondary outcomes

  1. Overall response rate (ORR)

    Time frame: Up to 6 cycles (every cycle is 21 days)

    The proportion of patients who achieve complete response (CR) or partial response (PR).

  2. Duration of Response (DOR)

    Time frame: Up to 5 years

    To investigate the preliminary anti-tumor efficacy

  3. Progression-free survival (PFS)

    Time frame: Up to 5 years

    To investigate the preliminary anti-tumor efficacy

  4. Overall survival (OS)

    Time frame: Up to 5 years

    To investigate the preliminary anti-tumor efficacy

Study contacts

Contact information is provided by the study sponsor or research team.

Qingqing Cai, MD. PhD.

CONTACT

[email protected]

+8602087342823

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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