A Phase 3 Study Comparing Pirtobrutinib (LOXO-305) to Bendamustine plus Rituximab in Untreated Patients with CLL/SLL

JRCT ID: jRCT2041210150

Registered date:18/02/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
• Date of first enrollment: 09/12/2021
• Target sample size: 12
• 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,Netherlands,Japan,New Zealand,Japan,Norway,Japan,Poland,Japan,Russian Federation,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): LOXO-305 as monotherapy 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

- Age 20 years or older per local regulations at time of enrollment
- Confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria
- A requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Must have adequate organ function
- Willingness of men and women of childbearing potential, and their partners, to both observe highly effective birth control methods for the duration of treatment and for 6 months following the last dose of study treatment or 12 months after the last dose of rituximab, whichever is later
- Willing and capable of giving signed informed consent
- Able to swallow oral study medication
- Able to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation

Exclude criteria

- Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin lymphoma at any time preceding enrollment.
- Presence of 17p deletion by fluorescence in-situ hybridization (FISH).
- Known or suspected history of central nervous system (CNS) involvement by CLL/SLL.
- Active second malignancy.
- Major surgery, within 4 weeks of planned start of study treatment.
- A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic, that, in the opinion of the Investigator, would adversely affect the patient's participation in this study or interpretation of study outcomes.
- Significant cardiovascular disease.
- Hepatitis B or hepatitis C testing indicating active/ongoing infection based on Screening laboratory tests.
- Active cytomegalovirus (CMV) infection.
- Evidence of other clinically significant uncontrolled condition(s).
- Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count. Patients with unknown or negative status are eligible.
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the oral administered study treatments.
- Prior systemic therapy for CLL/SLL.

Related Information

• Primary Sponsor: Safi Shahda
• Secondary ID(s): NCT05023980