Back
to List/Filter
Trial Acronym
LOXO-BTK-20030
Registration Number
NCT05254743
Scientific Title
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)
Brief Summary
Key Inclusion Criteria
Key Exclusion Criteria
Trial Locations
Primary Sponsor
The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years.
- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 - Adequate organ function - Platelets greater than or equal to (=)50 x 10?/liter (L) or =30 x 10?/L in participants with documented bone marrow involvement considered to impair hematopoiesis, - Hemoglobin =8 grams/deciliter (g/dL) or =6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis - Absolute neutrophil count =0.75 x 10?/L or =0.50 × 10?/L in participants with documented bone marrow involvement considered to impair hematopoiesis - Kidney function: Estimated creatinine clearance =30 milliliters per minute (mL/min)
- Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment - Known or suspected central nervous system (CNS) involvement - A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease - Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP]) - Significant cardiovascular disease including ejection fraction < 40% and any grade ongoing atrial fibrillation or atrial flutter - Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests - Active cytomegalovirus (CMV) infection - Active uncontrolled systemic bacterial, viral, or fungal infection - Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count - Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments - Ongoing inflammatory bowel disease - Prior exposure to BTK inhibitor (covalent or noncovalent) - Concurrent use of investigational agent or anticancer therapy except hormonal therapy - Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist - Use of = 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug - Vaccination with a live vaccine within 28 days prior to randomization - Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment - Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib
Trial Location Name
Address
Status
Dunedin Hospital (Haematology)
Dunedin Hospital Great King Street, Central Dunedin, Dunedin, New Zealand
Recruiting
Primary Contact :
Cancer & blood trials coordinator Dunedin Hospital,
oncresearch@southerndhb.govt.nz
, N/A
Waikato Hospital (Haematology)
Pembroke Street, Hamilton West, Hamilton 3204, New Zealand
Closed
Primary Contact :
Cancer & blood trials coordinator Waikato,
CBRTU-Enquiries@waikatodhb.health.nz
, N/A
Western Health (Haematology)
Western Health, Furlong Road, St Albans VIC, Australia
Recruiting
Primary Contact :
Heike Raunow,
Heike.Raunow@wh.org.au
, +613 8395 9167
Loxo Oncology, Inc.
Website URL
Link Name
Link URL
ANZCTR
http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT05254743
Clinicaltrials.gov
https://clinicaltrials.gov/ct2/show/NCT05254743
Secondary IDs
J2N-OX-JZNU18281
Study Type
Interventional
Intervention Code
Treatment - Drugs
Phase
Phase 3
Minimum Age
18
Maximum Age
100
Date Registered
10/11/2023
Date Closed
N/A
Status
Open
Enrolment Type
By Specialist and/or Surgeon Referral
Mutation Status and Biomarker
Any or not stated
Is it a Cohort Trial?
No
Is this a Tele-Trial?
No
Can healthy volunteer participate?
No
Discipline
Health Condition
Category
Sub Category
Haematology
Leukaemia (all trials)
Chronic Lymphocytic (CLL)
Newly Diagnosed
Relapsed/Refractory
Myelodysplastic Disorders (MDS)
N/A
N/A
Trial ID
23110009