A Phase 2 Trial of Single-Agent Pirtobrutinib for Elderly Patients With CLL
Jennifer Woyach
Summary
This phase II trial studies how well pirtobrutinib works in treating elderly patients with chronic lymphocytic leukemia (CLL). Bruton tyrosine kinase (BTK) inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib work by blocking the action of the BTK protein that signals cancer cells to multiply. These are very effective, tolerable, and commonly used to treat people with CLL, but they may lead to drug resistance over time. Pirtobrutinib, also a BTK inhibitor, may work better in treating elderly patients with CLL.
Description
PRIMARY OBJECTIVE: I. To evaluate rate of discontinuation and overall response rate (ORR) of pirtobrutinib after 12 cycles in patients who are ≥ 75 with CLL. SECONDARY OBJECTIVE: I. To assess the safety and efficacy of patients with CLL treated with pirtobrutinib. EXPLORATORY OBJECTIVE: I. Assess the treatments effect on quality of life and on geriatric assessments. OUTLINE: Patients receive pirtobrutinib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomog…
Eligibility
- Age range
- 75+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Men and women ≥ 75 years of age * Diagnosis of CLL/small lymphocytic lymphoma (SLL) meeting criteria established in the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines * Must be treatment-naive: Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptoms control. For radiation, broad field radiation (≥ 30% of bone marrow or whole brain radiotherapy) must be completed 14 days befo…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureBone Marrow Aspiration
Undergo bone marrow biopsy and aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy and aspiration
- ProcedureComputed Tomography
Undergo CT
- OtherElectronic Health Record Review
Ancillary studies
- DrugPirtobrutinib
Given PO
- OtherQuestionnaire Administration
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio