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Not yet recruitingNCT07184788Updated Sep 22, 2025

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

A Phase 2 interventional study of Glofitamab, Polatuzumab Vedotin, Gemcitabine, and Oxaliplatin as Induction Therapy in Aggressive B-Cell Lymphoma, sponsored by Navy General Hospital, Beijing. Not yet recruiting. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Navy General Hospital, Beijing · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
14 Years and older
Sex
All
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Study 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.

Read the detailed description

The investigators will evaluate safety and efficacy of G-Pola-GemOx as induction therapy in Refractory/Relapsed Aggressive B-Cell Lymphoma. ORR(Overall response rate, progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.

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Conditions studied

  • Aggressive B-Cell Lymphoma
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In context

Lead sponsor

Navy General Hospital, Beijing is the lead sponsor of 36 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Induction Therapy

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

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

Interventions

  • DrugGlofitamab, Polatuzumab Vedotin, Gemcitabine, and Oxaliplatin as Induction Therapy

    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

06

What researchers measure

Primary outcomes

  1. Overall Response Rate (ORR)

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

    Time frame: 1 year

Secondary outcomes

  1. Overall Survival (OS)

    OS was defined as time from diagnosis to death from any cause or the last follow-up

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

  2. Progression Free Survival (PFS)

    For patients in morphologic remission, documented relapse was considered progression. Relapse following complete remission(CR) is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse.

    Time frame: 2 years]

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07184788
Lead sponsor
Navy General Hospital, Beijing
Responsible party
Liren Qian (Associate Chief Physician, Associate Professor, Navy General Hospital, Beijing) — Principal investigator
First posted
Sep 22, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Oct 1, 2030 (estimated)
Completion
Oct 1, 2031 (estimated)
Last update
Sep 22, 2025

Study contacts

Liren Qian
Contact
qlr2007@126.com
+861066947194
Liren Qian
Contact
Liren Qian
principal investigator · Navy General Hospital, Beijing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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