LOXO-305 for Mantle Cell Lymphoma

(BRUIN-MCL-321 Trial)

Recruiting at 334 trial locations

Overseen By Patient Advocacy

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Loxo Oncology, Inc.

Must not be taking: BTK inhibitors, CYP3A4 inducers

Disqualifiers: Bleeding diathesis, Stroke, Cardiovascular, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

500 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires stopping ongoing chronic treatment with strong CYP3A4 inhibitors or inducers before starting the study drug. If you are on such medications, you may need to stop them within 3-5 half-lives of the medication before beginning the trial.

What is the purpose of this trial?

This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

Research Team

Patient Advocacy

Principal Investigator

Loxo Oncology, Inc.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

I have not had a stroke or brain bleed in the last 6 months.

I have a condition that affects how my stomach and intestines absorb food.

I have not had a stem cell transplant or CAR-T therapy in the last 60 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pirtobrutinib or an investigator's choice of BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib) for up to 24 months

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term if the disease does not progress

Long-term

Treatment Details

Interventions

• LOXO-305

Trial Overview 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.

Participant Groups

Group I: Arm A (Pirtobrutinib) Experimental Treatment 1 Intervention

Orally

Group II: Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib) Active Control 3 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.

Who Is Running the Clinical Trial?

Loxo Oncology, Inc.

Lead Sponsor

Trials

72

Recruited

11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University