Pola-ZR2P in Previously Untreated DLBCL

Phase 2

Not yet recruiting

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

• Registration Number: NCT06664411
• Lead Sponsor: Navy General Hospital, Beijing

Brief Summary

The goal of this phase 2 trial is to test the safety and efficacy of Pola-ZR2P as induction therapy in patients with DLBCL.

Detailed Description

The investigators will evaluate safety and efficacy of Pola-ZR2P 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: 2024-10-26
• Study First Submitted QC: 2024-10-27
• Last Update Submitted: 2024-10-27
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Study Start: 2024-12
• Primary Completion: 2029-12
• Study Completion: 2030-12

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
Pola-ZR2P	Polatuzumab Vedotin, Zanubrutinib, Rituximab, Lenalidomide and Prednisone as Induction Therapy	Patients were treated by Pola-ZR2P 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

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

Trial Locations

Locations (1)

Navy General Hospital; 🇨🇳 Beijing, Beijing, China