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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04662255
Registration number
NCT04662255
Ethics application status
Date submitted
4/12/2020
Date registered
10/12/2020
Titles & IDs
Public title
Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
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Scientific title
A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)
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Secondary ID [1]
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J2N-OX-JZNM
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Secondary ID [2]
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LOXO-BTK-20019
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Universal Trial Number (UTN)
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Trial acronym
BRUIN-MCL-321
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Mantle-Cell
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Pirtobrutinib
Treatment: Drugs - Ibrutinib
Treatment: Drugs - Acalabrutinib
Treatment: Drugs - Zanubrutinib
Experimental: Arm A (Pirtobrutinib) - Orally
Active comparator: Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib) - 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: Drugs: Pirtobrutinib
Oral
Treatment: Drugs: Ibrutinib
Oral
Treatment: Drugs: Acalabrutinib
Oral
Treatment: Drugs: Zanubrutinib
Oral
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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Assessed per Lugano criteria
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Timepoint [1]
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Up to approximately 24 months
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Secondary outcome [1]
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To compare Event Free Survival (EFS) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
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Assessment method [1]
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Defined as the time from randomization to progressive disease (PD) or start of new treatment for MCL or withdrawal from trial due to toxicity or death
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Timepoint [1]
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Up to approximately 24 months
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Secondary outcome [2]
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To compare Time to Treatment Failure (TTTF) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
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Assessment method [2]
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Time from randomization to time when discontinuation criteria met
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Timepoint [2]
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Up to approximately 24 months
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Secondary outcome [3]
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Time to worsening (TTW) of MCL-related symptoms
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Assessment method [3]
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Using symptom questions identified from the European Organization for Research and Treatment of Cancer (EORTC) item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms.
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Timepoint [3]
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Up to approximately 24 months
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Secondary outcome [4]
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Comparative Tolerability as measured by proportion of time with high side effect burden
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Assessment method [4]
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Using 18 items covering 10 Patient Reported Outcome- Common Terminology Criteria for Adverse Events (PRO-CTCAE) concepts for frequency (0-5 with 5 as most frequent), and/or presence (0-1 with 1 being present), or Severity (0-5 with 5 as most severe) and/or presence (0-1 with 1 being present); these selective adverse events will be framed and then overall side effect burden will be ascertained with the Functional Assessment of Cancer Therapy (FACT) - Item GP5. The range of this item is 0 -4 with 4 as most bothersome.
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Timepoint [4]
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Up to approximately 24 months
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Secondary outcome [5]
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To compare Overall Response Rate (ORR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
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Assessment method [5]
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Assessed per Lugano criteria
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Timepoint [5]
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Up to approximately 24 months
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Secondary outcome [6]
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To compare Duration of Response (DOR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
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Assessment method [6]
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Assessed per Lugano criteria
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Timepoint [6]
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Up to approximately 24 months
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Secondary outcome [7]
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To compare Overall Survival of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
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Assessment method [7]
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Assessed by survival
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Timepoint [7]
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Up to approximately 24 months
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Eligibility
Key inclusion criteria
* Confirmed MCL diagnosis
* Previously treated with at least one prior line of systemic therapy for MCL
* Measurable disease per Lugano criteria
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Absolute neutrophil count = 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
* Hemoglobin = 8 g/dL not requiring transfusion support or growth factors within 7 days of screening
* Platelets = 50 × 109/L not requiring transfusion support or growth factors within 7 days of screening.
* AST and ALT = 3.0 x upper limit of normal (ULN)
* Total bilirubin = 1.5 x ULN.
* Creatinine clearance of = 30 mL/min according to Cockcroft/Gault Formula
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior treatment with an approved or investigational BTK inhibitor
* History of bleeding diathesis
* History of stroke or intracranial hemorrhage within 6 months of randomization
* History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified T-cell (CAR-T) therapy within 60 days of randomization
* Clinically significant cardiovascular disease
* Prolonged QT interval corrected using Fridericia's formula (QTcF) > 470 ms on 2/3 consecutive ECGs, and mean QTcF>470 ms on all 3 ECGs
* Known HIV infection or active HBV, HCV, or CMV infections. (Certain participants with controlled HBV infections may still be eligible)
* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption
* Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment.
* Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
* Vaccination with live vaccine within 28 days prior to randomization
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/04/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2026
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
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Recruitment hospital [1]
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The St. George Hospital - Kogarah
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Recruitment hospital [2]
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Flinders Medical Centre - Adelaide
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Royal Hobart Hospital - Hobart
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Andrew Lowe Cancer Centre - Geelong
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Linear Clinical Research Ltd - Nedlands
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Royal Perth Hospital - Perth
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Recruitment hospital [7]
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Icon Cancer Care - The Wesley Medical Centre - Auchenflower
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2217 - Kogarah
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Recruitment postcode(s) [2]
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5042 - Adelaide
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7000 - Hobart
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Recruitment postcode(s) [4]
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3220 - Geelong
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Recruitment postcode(s) [5]
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WA6009 - Nedlands
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Recruitment postcode(s) [6]
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6000 - Perth
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Recruitment postcode(s) [7]
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4066 - Auchenflower
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Recruitment outside Australia
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Japan
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Hiroshima
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Japan
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Kumamoto
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Japan
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Kyoto-shi
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Japan
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Okayama
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Korea, Republic of
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Incheon-gwangyeoksi [Incheon]
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Korea, Republic of
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Seogu
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Korea, Republic of
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Seoul, Korea
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Korea, Republic of
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Seoul-teukbyeolsi [Seoul]
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Korea, Republic of
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Seoul
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Korea, Republic of
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Busan
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Netherlands
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Den Haag
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Netherlands
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Roosendaal
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Netherlands
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Rotterdam
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Netherlands
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TM Hoofddorp
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Poland
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Lubelskie
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Poland
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Pomorskie
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Poland
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Krakow
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Poland
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Skórzewo
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Poland
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Wroclaw
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Poland
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Lódz
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Portugal
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Lisboa
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Russian Federation
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Omskaya Oblast'
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Spain
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Andalucia
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Spain
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Barcelona
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Spain
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A Coruña
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Sevilla
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Spain
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Valencia
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Switzerland
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Luzern
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Switzerland
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Bellinzona
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Taiwan
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Taipei
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Taiwan
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Chiayi County
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taoyuan City
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United Kingdom
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Aberdeen City
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United Kingdom
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Oxford
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United Kingdom
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Stratchclyde
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United Kingdom
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Surrey
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United Kingdom
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Newmarket
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United Kingdom
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Nottingham
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United Kingdom
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Plymouth
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United Kingdom
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Windsor
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Loxo Oncology, Inc.
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Address
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
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Eli Lilly and Company
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Address [1]
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0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04662255
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Trial related presentations / publications
Eyre TA, Shah NN, Dreyling M, Jurczak W, Wang Y, Cheah CY, Song Y, Gandhi M, Chay C, Sharman J, Andorsky DJ, Messersmith HM, Ruppert AS, Muthig VA, Ito R, Wang ML. BRUIN MCL-321: phase III study of pirtobrutinib versus investigator choice of BTK inhibitor in BTK inhibitor naive mantle cell lymphoma. Future Oncol. 2022 Nov;18(36):3961-3969. doi: 10.2217/fon-2022-0976. Epub 2022 Nov 15. Ito R, Eyre TA, Shah NN, Gouill SL, Dreyling M, Vandenberghe E, Jurczak W, Wang Y, Cheah CY, Gandhi M, Chay C, Sharman J, Andorsky DJ, Song Y, Stark A, Muthig V, Wang ML. MCL-135 BRUIN MCL-321, a Phase 3 Open-Label, Randomized Study of Pirtobrutinib Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated, BTK Inhibitor Naive Mantle Cell Lymphoma (Trial in Progress). Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S395-S396. doi: 10.1016/S2152-2650(22)01570-1.
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Public notes
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Contacts
Principal investigator
Name
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0
Patient Advocacy
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Address
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Loxo Oncology, Inc.
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0
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04662255