A Phase 3 Study Comparing Pirtobrutinib to Ibrutinib in CLL/S

Phase 3

• Conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

• Registration Number: JPRN-jRCT2021220024
• Lead Sponsor: Escalon Mari

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 5

Inclusion 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.
- 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

Exclusion Criteria

-Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin lymphoma at any time preceding enrollment.
-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 exposure to BTK inhibitor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified