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BTK Inhibitor

Cohort A for Mantle Cell Lymphoma

Phase 2

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and adverse events (AEs)

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

Rituximab

1999

Completed Phase 4

~1880

Pirtobrutinib

2020

Completed Phase 1

~240

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,975 Previous Clinical Trials

1,789,459 Total Patients Enrolled

Preetesh Jain, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Preetesh Jain, MBBS, MD, DM, PhDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently open spots for participants in this ongoing clinical trial?

"As per the details outlined on clinicaltrials.gov, patient recruitment for this particular trial is currently inactive. The initial posting of the study was made on 8/31/2024 with the latest update noted on 2/9/2024. Despite this trial being in a non-recruitment phase, it is worth noting that there are approximately 1689 other ongoing trials actively seeking participants."

Answered by AI

What is the safety profile of Cohort A for individuals?

"Rated at 2, the safety of Cohort A has been evaluated by our team at Power. This score is attributed due to being in Phase 2 of the trial where there exists some evidence backing its safety but none supporting efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

2024. "Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06263491.

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