A Phase 3 Study of combination LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

JRCT ID: jRCT2011210061

Registered date:08/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
• Date of first enrollment: 08/01/2022
• Target sample size: 14
• Countries of recruitment: United States,Japan,Italy,Japan,Australia,Japan,Spain,Japan,Germany,Japan,Belgium,Japan,Canada,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Hungary,Japan,Ireland,Japan,Israel,Japan,Poland,Japan,South Korea,Japan,Sweden,Japan,Switzerland,Japan,Taiwan,Japan,United Kingdom,Japan,Singapore,Japan,Norway,Japan,China,Japan
• Study type: Interventional
• Intervention(s): LOXO-305 plus venetoclax plus rituximab or venetoclax plus rituximab

Outcome(s)

• Primary Outcome: PFS per International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2018) by Independent Review Committee (IRC)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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 10^9/liter (L), hemoglobin =>8 grams/deciliter (g/dL) and absolute neutrophil count =>1.0 x 10^9/L
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Estimated creatinine clearance =>30 milliliters per minute (mL/min)

Exclude criteria

- Known or suspected Richter's transformation at any time preceding enrollment
- 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
- 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:
- Known hypersensitivity to any component or excipient of LOXO-305 and venetoclax
- Prior significant hypersensitivity to rituximab
- Known allergy to allopurinol and inability to take uric acid lowering agent

Related Information

• Primary Sponsor: Chang Amy
• Secondary ID(s): NCT04965493