Pola-ZR2P in Previously Untreated DLBCL

NCT06664411 | Recruiting Phase 2

• 1 other identifier: PRIME01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression was defined according to the Lugano Response Criteria

  2 years

Secondary Outcomes (2)

• Overall Survival (OS)

  through study completion, an average of 2 years

• Overall Response Rate (ORR)

  1 year

Study Arms (1)

Pola-ZR2P

EXPERIMENTAL

Patients were treated by Pola-ZR2P as Induction Therapy

Drug: Polatuzumab Vedotin, Zanubrutinib, Rituximab, Lenalidomide and Prednisone as Induction Therapy

Interventions

Polatuzumab Vedotin, Zanubrutinib, Rituximab, Lenalidomide and Prednisone as Induction Therapy DRUG

Patients were treated by Polatuzumab Vedotin(1.8mg/kg iv qd d1), Zanubrutinib(160mg po bid d1-21), Rituximab(375mg/m2 iv qd d1), Lenalidomide(25mg po qd d1-14) and Prednisone(60mg/m2 po qd d1-5) as induction therapy

Also known as: Pola-ZR2P

Pola-ZR2P

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

Study Sites (1)

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

polatuzumab vedotin; zanubrutinib; Rituximab; Lenalidomide; Prednisone; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Combined Modality Therapy; Therapeutics

Study Officials

• Liren Qian, PhD

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liren Qian, PhD

CONTACT

+861066947194; qlr2007@126.com

Liren Qian, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Associate Professor

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: October 29, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

CN (1)