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

NCT ID: NCT07184788

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2031-10-01

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.

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.

Conditions

Aggressive B-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction Therapy

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

Glofitamab, 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.

Intervention Type: DRUG

Other Intervention Names

G-Pola-GemOx

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Navy General Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Liren Qian

Associate Chief Physician, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liren Qian

Role: PRINCIPAL_INVESTIGATOR

Navy General Hospital, Beijing

Central Contacts

Liren Qian

Role: CONTACT

qlr2007@126.com

+861066947194

Liren Qian

Role: CONTACT

Other Identifiers

G-POLARGO

Identifier Type: -

Identifier Source: org_study_id