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A Phase 3 Trial of Fixed Duration Pirtobrutinib (LOXO-305) plus Venetoclax and Rituximab versus Venetoclax and Rituximab in Previously Treated CLL/SLL
EU CTIS ID: 2023-507698-16-00
What this study is testing
Progression-free survival
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18 and older at time of enrollment
- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
- Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
- Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10⁹/L
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
You likely can't join if
- Known or suspected Richter's transformation at any time preceding enrollment
- Active hepatitis B or hepatitis C
- Known active cytomegalovirus (CMV) infection
- Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
- Significant cardiovascular disease
- Vaccination with a live vaccine within 28 days prior to randomization
See the full eligibility criteria
- Age 18 and older at time of enrollment
- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
- Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
- Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10⁹/L
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
- Known or suspected Richter's transformation at any time preceding enrollment
- Active hepatitis B or hepatitis C
- Known active cytomegalovirus (CMV) infection
- Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
- Significant cardiovascular disease
- Vaccination with a live vaccine within 28 days prior to randomization
- Patients with the following hypersensitivity: 1. Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax 2. Prior significant hypersensitivity to rituximab 3. Known allergy to allopurinol and inability to take uric acid lowering agent
- Prior therapy with a non-covalent (reversible) BTK inhibitor
- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
- Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers
- Prior therapy with venetoclax
- Central nervous system (CNS) involvement
- Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
- Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days
The study team makes the final eligibility decision.
Where it's taking place
- Singapore
- Switzerland
- Japan
- China
- Taiwan
- Korea, Republic of
- United States
- Israel
- Australia
- United Kingdom
- Russian Federation
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore; Switzerland; Japan; China; Taiwan; Korea, Republic of and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.