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

Recruiting in Palo Alto (17 mi)

+276 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Loxo Oncology, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

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.

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).

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

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

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

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

My platelet count is above 50 without needing transfusions recently.

Exclusion Criteria

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.

I need blood thinners like warfarin for my condition.

I have been treated with a BTK inhibitor before.

I am not on long-term strong medications that affect liver enzyme CYP3A4, or I can stop them before starting the study drug.

I have a history of unusual bleeding.

I have a serious heart condition.

Participant Groups

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.

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.