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BTK Inhibitor

Pirtobrutinib + Rituximab for Lymphoma

Phase 2

Recruiting

Led By Preetesh Jain, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Pathology confirmed diagnosis of mantle cell lymphoma with CD20 positivity

Low risk criteria: Ki-67% (≤ 30%), largest tumor size ≤ 3 cm, no features of high-risk disease

Must not have

Concomitant use of steroids for disease related pain control

Severe acute or chronic medical or psychiatric conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a combination of pirtobrutinib and rituximab can be effective in treating newly diagnosed mantle cell lymphoma without the use of chemotherapy.

Who is the study for?

This trial is for people newly diagnosed with a type of cancer called Mantle Cell Lymphoma (MCL), specifically those who are considered low or intermediate risk and have not yet been treated. The specific eligibility criteria to join the study were not provided.

What is being tested?

The study is testing a combination of two drugs, Pirtobrutinib and Rituximab, in patients with MCL. It aims to find out if this chemotherapy-free treatment can control the disease effectively.

What are the potential side effects?

While specific side effects for this trial weren't listed, generally Rituximab can cause reactions like fever, chills, infections; Pirtobrutinib may also have its own set of side effects which will be monitored.

Eligibility Criteria

Inclusion Criteria

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

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My lymphoma is confirmed to be mantle cell type and tests positive for CD20.

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My cancer is low risk with a small tumor size and no high-risk features.

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I am a woman who cannot become pregnant due to surgery, menopause, or a negative pregnancy test.

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My doctor expects me to live more than 12 weeks with my lymphoma.

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I am 18 years old or older.

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I am over 18 and have just been diagnosed with mantle cell lymphoma without any prior treatment.

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I can walk and take care of myself without help.

Exclusion Criteria

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

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I am using steroids for cancer-related pain.

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I have severe ongoing health or mental health issues.

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I have a history of unusual bleeding.

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I have an active CMV infection.

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

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I am HIV positive or have an active hepatitis B/C infection.

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I have had a transplant or graft-versus-host disease.

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I have not been cancer-free for at least a year from any other cancer.

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I have a serious heart condition.

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I do not have uncontrolled immune-related blood disorders.

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My lymphoma has spread to my brain or I might have a brain infection.

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I do not have any uncontrolled health conditions.

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I am currently taking specific medications.

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I had severe bleeding or heart rhythm problems with a previous BTK inhibitor treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort BExperimental Treatment2 Interventions

If participants test positive for MRD at the 24 month time point, participants will be in Cohort B and the participant will continue taking pirtobrutinib.

Group II: Cohort AExperimental Treatment2 Interventions

If participants show that they have no MRD, participants will be in Cohort A and will stop taking pirtobrutinib. Participants will continue to be observed and tested for MRD, and participants will be able to continue receiving the drug if you test positive.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pirtobrutinib

2020

Completed Phase 1

~240

Rituximab

1999

Completed Phase 4

~2990