G-Pola-ZLP in Diffuse Large B-Cell Lymp… | Clinical Trial

Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

The investigators will evaluate safety and efficacy of G-Pola-ZLP as induction therapy in Previously Untreated Diffuse Large B-Cell Lymphoma. ORR(Overall response rate, progression-free survival (PFS), Overall survival (OS), Adverse events (AEs) will be assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification;
Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
Patient has not received chemotherapy previously.
Anticipated life expectancy at least 3 months

Exclusion criteria

Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
Pregnant or lactating women

Treatment and study plan

Glofitamab, Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Prednisone as Induction Therapy

Drug

Patients were treated by Glofitama(Cycle 1: D8, 2.5mg, D15, 10mg; followed by the target dose of 30mg on D1 of Cycle 2-12), Polatuzumab Vedotin(1.8mg/kg iv qd d1), Zanubrutinib(160mg po bid d1-21), Lenalidomide(25mg po qd d1-14) and Prednisone(60mg/m2 po qd d1-5) as induction therapy.

Other names: G-Pola-ZLP

Primary outcomes

Overall Response Rate (ORR)

Time frame: 1 year

ORR was defined as the proportion of patients who achieved CR or PR as their best response

Secondary outcomes

Overall Survival (OS)

Time frame: through study completion, an average of 2 years

OS was defined as time from diagnosis to death from any cause or the last follow-up
Progression Free Survival (PFS)

Time frame: 2 years

Progression was defined according to the Lugano Response Criteria

Study contacts

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

Liren Qian, PhD

CONTACT

[email protected]

+861066947194

Liren Qian, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Navy General Hospital, Beijing

Other

Registry information

Official study title

Glofitamab, Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Prednisone in Previously Untreated Diffuse Large B-Cell Lymphoma

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2030
First posted: Oct 30, 2024
Registry last updated: Aug 14, 2025

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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