Pola-ZR2P in Previously Untreated DLBCL

Navy General Hospital, Beijing

Status and phase

Enrolling

Phase 2

Conditions

Diffuse Large B-cell Lymphoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06664411

PRIME01

Details and patient eligibility

About

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

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

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