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BTK Inhibitor

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

São Paulo, Brazil
Phase 3
Waitlist Available
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
Must not have
Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption
History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified T-cell (CAR-T) therapy within 60 days of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that affects how my stomach and intestines absorb food.
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I have not had a stem cell transplant or CAR-T therapy in the last 60 days.
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I need blood thinners like warfarin for my condition.
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I have been treated with a BTK inhibitor before.
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I am not on long-term strong medications that affect liver enzyme CYP3A4, or I can stop them before starting the study drug.
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I have a history of unusual bleeding.
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I have a serious heart condition.

Timeline

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

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

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT05176314
9%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
20 mg Rosuvastatin (Day 1)
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 13)
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 6)
200 mg Pirtobrutinib QD (Days 7-12)
200 mg Pirtobrutinib QD (Days 14-17)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Closest Location:Cross Cancer Institute· Edmonton, Canada

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,680 Previous Clinical Trials
3,465,884 Total Patients Enrolled
Loxo Oncology, Inc.Lead Sponsor
71 Previous Clinical Trials
10,560 Total Patients Enrolled
Patient AdvocacyStudy DirectorLoxo Oncology, Inc.
Jennifer Kherani, MDStudy DirectorLoxo Oncology

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
~91 spots leftby Dec 2025