Pirtobrutinib for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Jennifer Woyach
- Study ID
- NCT07685717
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 75 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo collection of blood samples
- Bone Marrow Aspiration — PROCEDUREUndergo bone marrow biopsy and aspiration
- Bone Marrow Biopsy — PROCEDUREUndergo bone marrow biopsy and aspiration
- Computed Tomography — PROCEDUREUndergo CT
- Electronic Health Record Review — OTHERAncillary studies
- Pirtobrutinib — DRUGGiven PO
- Questionnaire Administration — OTHERAncillary studies
Study Details
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.
Key Dates
- Start date
- Aug 1, 2026
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (pirtobrutinib)Patients receive pirtobrutinib PO 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 CT, blood sample collection, and bone marrow biopsy and aspiration throughout the study.
Primary Outcome Measure
Rate of treatment discontinuation [ Time Frame: Up to 12 cycles (Cycle length = 28 days) ]
Central Contacts
- The Ohio State University Comprehensive Cancer Center1-800-293-5066
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Jennifer A. Woyach, MD (PRINCIPAL_INVESTIGATOR) |
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