Pirtobrutinib With Rituximab for the Treatment of Newly Diagnosed Marginal Zone Lymphoma

Marginal Zone Lymphoma Clinical Trial

Official title: A Phase II Study of Pirtobrutinib in Combination With Rituximab in Newly Diagnosed Marginal Zone Lymphoma: A Risk Adapted Approach

Status Not yet recruiting

Clinical Trial Summary

This phase II trial tests how well pirtobrutinib in combination with rituximab works in treating patients with marginal zone lymphoma (MZL). Pirtobrutinib is a BTK inhibitor. It works by blocking the action of the protein that signals tumor cells to multiply. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving pirtobrutinib in combination with rituximab may be an effective treatment for MZL.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To assess the efficacy of the combination of pirtobrutinib and rituximab based on overall response rate (ORR) at the end of cycle (C) 6.

SECONDARY OBJECTIVES:

I. Complete response (CR) rate at end of C6. II. Duration of response (DOR). III. Median and 2-year progression-free survival (PFS). IV. Median and 2-year overall survival (OS).

EXPLORATORY OBJECTIVES:

I. To determine the rate of undetectable minimal residual disease (uMRD) at end of C6 and C12.

II. To characterize BTK and PLCG2 gene mutations, concurrently activated oncogenic pathways and the pharmacodynamic response to treatment from peripheral, bone marrow and/or tumor/lymph node biopsies before and during treatment and after disease progression (PD), in select patients.

OUTLINE:

Patients receive pirtobrutinib orally (PO) once daily (QD) on days 1-28 and rituximab intravenously (IV) on day 1 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients with a CR receive pirtobrutinib for an additional 6 cycles and patients with partial response (PR) or stable disease (SD) receive pirtobrutinib and rituximab for an additional 6 cycles. Patients who then achieve a CR after cycle 12 may continue pirtobrutinib for an additional 6 cycles. Patients with a PR or SD after cycle 12 may continue pirtobrutinib until PD. Patients also undergo blood sample collection, computed tomography (CT) or positron emission tomography (PET)/CT and PET throughout the study. Patients may also undergo tissue biopsy at screening and relapse.

After completion of study treatment, patients are followed up at 30 days, every 3 months up to disease progression or next anticancer treatment then every 6 months. ;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Marginal Zone Lymphoma

• NCT number: NCT06390956
• Study type: Interventional
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials@osumc.edu
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Completion date: December 31, 2025