Clinical Trials List
Protocol NumberLOXO-BTK-20030 (J2N-OX-JZNU)
NCT Number(ClinicalTrials.gov Identfier)NCT05254743
Active
2022-04-30 - 2028-09-30
Phase III
Recruiting5
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)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳敬炫 Division of Hematology & Oncology
- Ta-Chih Liu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- Ta-Chih Liu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Tsai-Yun Chen
Co-Principal Investigator
- Ya-Ping Chen Division of Hematology & Oncology
- 顏志傑 Division of Hematology & Oncology
- Chun-Hui Lee Division of Hematology & Oncology
- Ya-Ting Hsu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic Lymphocytic Leukemia
Objectives
This study was conducted to evaluate the safety and efficacy of an investigational treatment called pirtobrutinib compared to ibrutinib. Pirtobrutinib is an investigational (or experimental) drug that may be used to treat chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
The objectives of this study include:
1. Determining how well patients with chronic lymphocytic leukemia/small lymphocytic lymphoma respond to pirtobrutinib (Group A) compared to ibrutinib (Group B).
2. Determining the duration of any benefit from the investigational drug treatment (including patient survival).
3. Determining the safety and tolerability of Groups A and B.
4. Determining how patients in Group A felt compared to those in Group B.
Test Drug
錠劑
Active Ingredient
PIRTOBRUTINIB
Dosage Form
110
Dosage
MG
Endpoints
Primary Objective:
Assess the overall response rate (ORR) of pirtobrutinib (Group A) versus ibrutinib (Group B).
Secondary Objectives:
Assess the efficacy of Group A versus Group B based on event-free survival (EFS), progression-free survival (PFS), ORR, duration of response (DOR), overall survival (OS), and time to next treatment (TTNT).
Assess the safety and tolerability of each treatment group.
Assess patient-reported outcomes in Group A versus Group B.
Assess the overall response rate (ORR) of pirtobrutinib (Group A) versus ibrutinib (Group B).
Secondary Objectives:
Assess the efficacy of Group A versus Group B based on event-free survival (EFS), progression-free survival (PFS), ORR, duration of response (DOR), overall survival (OS), and time to next treatment (TTNT).
Assess the safety and tolerability of each treatment group.
Assess patient-reported outcomes in Group A versus Group B.
Inclution Criteria
Inclusion Criteria:
Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Adequate organ function
Platelets greater than or equal to ≥ 50 x 10⁹/liter (L) or ≥30 x 10⁹/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 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Adequate organ function
Platelets greater than or equal to ≥ 50 x 10⁹/liter (L) or ≥30 x 10⁹/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 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
Exclusion Criteria
Exclusion Criteria:
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
Previous treatment for CLL/SLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent).
Part 2: participants must be treatment naïve
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
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
Previous treatment for CLL/SLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent).
Part 2: participants must be treatment naïve
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
The Estimated Number of Participants
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Taiwan
40 participants
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Global
650 participants
