← Back to Search

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 7 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

Select...

My lymphoma type is confirmed as marginal zone lymphoma.

Select...

I am 18 years old or older.

Select...

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:

Select...

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

Select...

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

Select...

I have a history of unusual bleeding.

Select...

I do not have serious heart problems.

Select...

My cancer has spread to my brain or spinal cord.

Select...

I am positive for HIV, HBV, or HCV.

Select...

I need blood thinners like warfarin for my condition.

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 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

Objective response rate (ORR) defined as the proportion of subjects achieving a partial response (PR) or complete response (CR) by Lugano Criteria at Cycle 7.

Secondary study objectives

Duration of response (DoR), defined as the interval of time from the date of initial documented response (PR or better per Lugano Criteria) to the time of progression from the best response, the start of a new therapy, or death from any cause.

Median and two year Progression-free survival (PFS). PFS will be as defined as the time from study drug initiation to the time of documented disease progression (as assessed by Lugano Criteria), or death from any cause.

Median and two year overall survival (OS). OS is defined as the time from registration until death from any cause.

+1 more