A Phase 3 Study of LOXO-305 in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

JRCT ID: jRCT2021210031

Registered date:24/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
• Date of first enrollment: 14/02/2022
• Target sample size: 10
• Countries of recruitment: Australia,Japan,Austria,Japan,Belgium,Japan,Canada,Japan,China,Japan,Croatia,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,Hungary,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Poland,Japan,Russia,Japan,Singapore,Japan,Spain,Japan,South Korea,Japan,Switzerland,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): LOXO-305 as monotherapy, idelalisib plus rituximab or bendamustine 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 as defined by iwCLL 2018 criteria
- Previously treated with a covalent BTK inhibitor
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Absolute neutrophil count => 0.75 * 109/L without granulocyte-colony stimulating factor support
- Hemoglobin => 8 g/dL not requiring transfusion support or growth factors within 14 days of Cycle 1 Day 1
- Platelets => 50 * 109/L not requiring transfusion support or growth factors within 14 days of C1D1. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be => (75 * 109/L).
- AST and ALT <= 3.0 * upper limit of normal (ULN).
- Total bilirubin <= 1.5 * ULN.
- Estimated creatinine clearance of => 40 mL/min.

Exclude criteria

- Known or suspected Richter's transformation at any time preceding enrollment.
- Known or suspected history of central nervous system (CNS) involvement by CLL/SLL
- Ongoing drug-induced liver injury
- Active uncontrolled auto-immune cytopenia
- Significant cardiovascular disease
- History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor-modified T cells (CAR-T) therapy within the past 60 days
- Active hepatitis B or hepatitis C
- Known active cytomegalovirus (CMV) infection.
- Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
- Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count.
- Clinically significant active malabsorption syndrome or inflammatory bowel disease
- Prior exposure to 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 and/or strong P-glycoprotein (P-gp) inhibitors
- Vaccination with a live vaccine within 28 days prior to randomization
- Patients with the following hypersensitivity:
1) Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305, idelalisib, and bendamustine
2) Prior significant hypersensitivity to rituximab

Related Information

• Primary Sponsor: Shahda , MD Safi