Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07184788

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Aggressive B-Cell Lymphoma

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-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.

Who can participate

Healthy volunteers accepted: No

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

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

  • 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, 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.

Other names: G-Pola-GemOx

Primary outcomes

  1. 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

  1. 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

  2. Progression Free Survival (PFS)

    Time frame: 2 years]

    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.

Study contacts

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

Liren Qian

CONTACT

[email protected]

+861066947194

Liren Qian

CONTACT

Sponsors and collaborators

Lead sponsor

Navy General Hospital, Beijing

Other

Registry information

Official study title

Glofitamab，Polatuzumab Vedotin and GemOx in Refractory/Relapsed Aggressive B-Cell Lymphoma

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Sep 22, 2025
Registry last updated
Sep 22, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.