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Kinase Inhibitor

Nemtabrutinib + Rituximab for Mantle Cell Lymphoma

Phase 2

Waitlist Available

Led By Alexey V Danilov

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Diagnosis of MCL established by histologic assessment including immunohistochemistry of the biopsy or flow cytometry of the biopsy

Requiring treatment for MCL, and for which no prior systemic anticancer therapies have been received

Must not have

Chronic systemic corticosteroid use > 20 mg/day of prednisone or equivalent

History of severe bleeding disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how well a drug called nemtabrutinib works when given with rituximab for treating patients with mantle cell lymphoma. Nemtabrutinib is a medication that blocks

Who is the study for?

This trial is for patients with mantle cell lymphoma. Participants should have this type of cancer to be eligible. Specific inclusion and exclusion criteria are not listed, but typically these would cover health status, prior treatments, and other medical conditions.

What is being tested?

The trial is testing the effectiveness of combining nemtabrutinib, a kinase inhibitor that blocks proteins linked to B-cell cancers, with rituximab, an antibody that helps the immune system target cancer cells. It's a phase II study which means it's checking how well these drugs work together.

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal cells (due to rituximab), issues from blocking BTK protein like bleeding or infections (from nemtabrutinib), and general drug-related effects such as fatigue or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My Mantle Cell Lymphoma (MCL) was confirmed through biopsy tests.

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I need treatment for MCL and haven't had any cancer treatments before.

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My tests or symptoms indicate I have mantle cell lymphoma (MCL).

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My lymphoma can be measured on scans.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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My blood clotting time is normal or managed if I'm on blood thinners.

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My blood clotting time is normal or managed if I'm on blood thinners.

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I do not have hepatitis B or C, or if I do, it is under control.

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I am 18 years old or older.

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I can do most of my daily activities on my own.

Exclusion Criteria

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

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I take more than 20 mg/day of prednisone or its equivalent.

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I have a history of severe bleeding problems.

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I do not have unstable heart conditions.

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I do not have any uncontrolled serious illnesses.

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I do not have any active infections.

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My cancer is a type of lymphoma that affects the brain or spinal cord.

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I am allergic to nemtabrutinib or its ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5.5 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

Complete response rate

Secondary study objectives

Duration of response

Incidence of adverse events

Overall response rate

+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 (nemtabrutinib and rituximab)Experimental Treatment5 Interventions

INDUCTION: Patients receive nemtabrutinib PO QD on days 1-28 of each cycle and rituximab IV on days 1, 8, 15 and 22 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive nemtabrutinib PO QD on days 1-28 of each cycle and rituximab IV on day 1 of event numbered cycles. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may optionally continue to receive nemtabrutinib PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy during screening and may undergo throughout the trial and PET-CT scan and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nemtabrutinib

2023

Completed Phase 1

~100

Biospecimen Collection

2004

Completed Phase 3

~2030