G-Pola-GemOx in Refractory/Relapsed Aggressive B-Cell Lymphoma

NCT07184788 | Not Yet Recruiting Phase 2

• 1 other identifier: G-POLARGO
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this phase 2 trial is to test the safety and efficacy of G-Pola-GemOx as induction therapy in patients with Refractory/Relapsed Aggressive B-Cell Lymphoma.

Conditions

Aggressive B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

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

  1 year

Secondary Outcomes (2)

• Overall Survival (OS)

  through study completion, an average of 2 years

• Progression Free Survival (PFS)

  2 years]

Study Arms (1)

Induction Therapy

EXPERIMENTAL

Patients were treated by G-Pola-GemOx as Induction Therapy

Drug: Glofitamab, Polatuzumab Vedotin, Gemcitabine, and Oxaliplatin as Induction Therapy

Interventions

Glofitamab, Polatuzumab Vedotin, Gemcitabine, and Oxaliplatin 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), Gemcitabine (1000 mg/m2 iv qd d2), Oxaliplatin (100 mg/m2 iv qd d2) as induction therapy.

Also known as: G-Pola-GemOx

Induction Therapy

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed Aggressive B-Cell Lymphoma (Including but not limited to diffuse large B-cell lymphoma, mantle cell lymphoma, Burkitt lymphoma, high-grade B-cell lymphoma, etc. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

MeSH Terms

Interventions

glofitamab; polatuzumab vedotin; Gemcitabine; Oxaliplatin; Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics

Study Officials

• Liren Qian

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liren Qian

CONTACT

+861066947194; qlr2007@126.com

Liren Qian

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Associate Professor

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2031
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share