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BTK Inhibitor

Pirtobrutinib + Rituximab for Marginal Zone Lymphoma

Phase 2

Waitlist Available

Led By Narendranath Epperla, MD, MS

Research Sponsored by Narendranath Epperla

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically documented marginal zone lymphoma, including splenic, nodal, and extranodal sub-types at the enrolling institution

Age ≥ 18 years

Must not have

Clinically significant active malabsorption syndrome or other condition affecting GI absorption

Major surgery within 4 weeks prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at initiation of treatment to death up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of pirtobrutinib and rituximab in treating patients with marginal zone lymphoma (MZL). Pirtobrutinib blocks a protein that

Who is the study for?

This trial is for patients newly diagnosed with marginal zone lymphoma, a type of cancer affecting white blood cells. Participants should be suitable for both biopsy and imaging tests like CT and PET scans to monitor the disease.

What is being tested?

The study is testing pirtobrutinib combined with rituximab as a treatment. Pirtobrutinib blocks proteins that help tumor cells grow, while rituximab targets certain immune cells potentially aiding in killing cancer cells.

What are the potential side effects?

Possible side effects include reactions at the infusion site, flu-like symptoms, low blood cell counts leading to increased infection risk or bleeding, fatigue, nausea, and potential liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma type is confirmed as marginal zone lymphoma.

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I am 18 years old or older.

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I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that affects how my body absorbs nutrients.

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I have not had major surgery in the last 4 weeks.

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I have a history of unusual bleeding.

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I do not have serious heart problems.

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My cancer has spread to my brain or spinal cord.

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I am positive for HIV, HBV, or HCV.

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I need blood thinners like warfarin for my condition.

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I haven't had any live-virus vaccines in the last 28 days and don't need any during the study.

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I have an active, uncontrolled immune system disorder affecting my blood cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at initiation of treatment to death up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at initiation of treatment to death up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at initiation of treatment to death up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

Complete response (CR) rate

Duration of response (DOR)

Incidence of adverse events (AEs)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pirtobrutinib, rituximab)Experimental Treatment6 Interventions

Patients receive pirtobrutinib PO QD on days 1-28 and rituximab 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 PR or 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, CT or PET/CT and PET throughout the study. Patients may also undergo tissue biopsy at screening and relapse.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Rituximab

1999

Completed Phase 4

~2990

Biospecimen Collection

2004

Completed Phase 3

~2020

Positron Emission Tomography

2011

Completed Phase 2

~2200

Pirtobrutinib

2020

Completed Phase 1

~240

Computed Tomography

2017

Completed Phase 2

~2740

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Narendranath EpperlaLead Sponsor

2 Previous Clinical Trials

27 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,658 Previous Clinical Trials

3,225,147 Total Patients Enrolled

Narendranath Epperla, MD, MSPrincipal InvestigatorOhio State University Comprehensive Cancer Center

2 Previous Clinical Trials

47 Total Patients Enrolled

~15 spots leftby Dec 2025

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