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

Navy General Hospital, Beijing

Status and phase

Not yet enrolling

Phase 2

Conditions

Aggressive B-Cell Lymphoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07184788

G-POLARGO

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

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