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BTK Inhibitor

LOXO-305 for Mantle Cell Lymphoma (BRUIN-MCL-321 Trial)

Phase 3

Recruiting

Research Sponsored by Loxo Oncology, Inc.

Eligibility Criteria Checklist

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

Must have

Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening

Confirmed MCL diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 24 months

Awards & highlights

BRUIN-MCL-321 Trial Summary

This trial is testing a new cancer drug against other approved drugs to see if it is more effective. It is for people with mantle cell lymphoma, a type of blood cancer, and could last up to two years.

Who is the study for?

This trial is for people with a blood cancer called mantle cell lymphoma (MCL) who have already tried at least one treatment. They should be relatively healthy, with good organ function and no major bleeding disorders or infections like HIV. People can't join if they've had certain recent treatments, need strong blood thinners, or have serious heart issues.Check my eligibility

What is being tested?

The study compares pirtobrutinib (LOXO-305), a new drug, to other approved drugs that target the same protein in MCL cells. Participants will receive their assigned treatment for up to two years or longer if it helps control the disease.See study design

What are the potential side effects?

Common side effects of BTK inhibitors include bruising, diarrhea, fatigue, fever, muscle pain and rash. Serious but less common side effects may involve bleeding problems, high blood pressure and infections.

BRUIN-MCL-321 Trial Eligibility Criteria

Inclusion Criteria

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

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My white blood cell count is healthy without needing medication in the past week.

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I have been diagnosed with mantle cell lymphoma (MCL).

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My hemoglobin level is at least 8 g/dL without needing transfusions or growth factors recently.

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I have received at least one treatment for my mantle cell lymphoma.

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

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My kidneys are working well enough (creatinine clearance ≥ 30 mL/min).

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My platelet count is above 50 without needing transfusions recently.

BRUIN-MCL-321 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)

Secondary outcome measures

Comparative Tolerability as measured by proportion of time with high side effect burden

Time to worsening (TTW) of MCL-related symptoms

To compare Duration of Response (DOR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms

+4 more

BRUIN-MCL-321 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (Pirtobrutinib)Experimental Treatment1 Intervention

Orally

Group II: Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib)Active Control3 Interventions

Investigator's choice (based on local availability) of ibrutinib, acalabrutinib or zanubrutinib orally. Options are limited to those that are available/approved in the specific country.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pirtobrutinib

2020

Completed Phase 1

~240

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor

2,618 Previous Clinical Trials

3,201,017 Total Patients Enrolled

Loxo Oncology, Inc.Lead Sponsor

66 Previous Clinical Trials

9,369 Total Patients Enrolled

Patient AdvocacyStudy DirectorLoxo Oncology, Inc.

Media Library

LOXO-305 (BTK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04662255 — Phase 3

Mantle Cell Lymphoma Research Study Groups: Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib), Arm A (Pirtobrutinib)

Mantle Cell Lymphoma Clinical Trial 2023: LOXO-305 Highlights & Side Effects. Trial Name: NCT04662255 — Phase 3

LOXO-305 (BTK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04662255 — Phase 3

Frequently Asked Questions

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

How large is the potential test group for this experiment?

"In order to move forward with the study, 500 patients that meet the inclusion criteria must be enrolled. The sponsor, Eli Lilly and Company, has different locations across Texas Oncology-Austin Midtown in Austin, British Columbia and BC Cancer Vancouver in Vancouver, Oregon where the trial will be conducted."

Answered by AI

Is this study being conducted at a significant number of facilities in this state?

"There are 65 different sites around the world where this trial is taking place, with some locations including Austin, Vancouver, Salem, and many others. It would be beneficial for those enrolling to try and be placed at a location near to them to limit travel."

Answered by AI

What is the main use for LOXO-305?

"LOXO-305 is a common course of treatment for lymphoma patients. This medication can also help patients battling small lymphocytic lymphoma, one prior therapy, and ≥ 1 prior therapy for mantle cell lymphoma."

Answered by AI

Are there any recognized dangers associated with LOXO-305?

"LOXO-305 has undergone Phase 3 trials, meaning that there is available data to support both its efficacy and safety. Consequently, our team has given it a safety rating of 3."

Answered by AI

What other drugs has LOXO-305 been tested against in clinical trials?

"LOXO-305 was first studied in 2011 at the National Institutes of Health Clinical Center. In the last decade, there have been a total of 142 completed clinical trials. Right now, there are 268 ongoing studies, with several taking place in Austin and British Columbia."

Answered by AI