G-Pola-ZLP in Diffuse Large B-Cell Lymphoma

Phase 2

Not yet recruiting

• Conditions: Diffuse Large B-Cell Lymphoma
• Interventions: Drug: Glofitamab, Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Prednisone as Induction Therapy

• Registration Number: NCT06665217
• Lead Sponsor: Navy General Hospital, Beijing

Brief Summary

The goal of this phase 2 trial is to test the safety and efficacy of G-Pola-ZLP as induction therapy in patients with DLBCL.

Detailed Description

The investigators will evaluate safety and efficacy of G-Pola-ZLP as induction therapy in Previously Untreated Diffuse Large B-Cell Lymphoma. ORR(Overall response rate, progression-free survival (PFS), Overall survival (OS), Adverse events (AEs) will be assessed.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30
• Study Start: 2025-01
• Primary Completion: 2029-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Pathologically confirmed Diffuse Large B Cell Lymphoma 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Induction Therapy	Glofitamab, Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Prednisone as Induction Therapy	Patients were treated by G-Pola-ZLP as Induction Therapy

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	1 year	ORR was defined as the proportion of patients who achieved CR or PR as their best response

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	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
Progression Free Survival (PFS)	2 years	Progression was defined according to the Lugano Response Criteria