Pirtobrutinib for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age75+
SponsorJennifer Woyach
About this trial
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.
Eligibility criteria
Qualifiers
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 before study enrollment; palliative limited field radiation must be completed 7 days prior to study enrollment. For rituximab, washout of 2 weeks is required prior to study enrollment
Must require treatment according to 2018 iwCLL guidelines
Disqualifiers
Active Richter's transformation (i.e. within 6 months of active therapy, or requiring treatment for Richter's transformation)
Malabsorption syndrome or inability to absorb pirtobrutinib
Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, those with uncontrolled arrhythmia, and those patients who experienced an myocardial infarction (MI) within 3 months of screening or acute coronary syndrome within 2 months of screening are not eligible
Documented left ventricular ejection fraction (LVEF) by any method of ≤ 40% in the 12 months prior to randomization
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Bone Marrow Aspiration
- Bone Marrow Biopsy
- Computed Tomography
- Electronic Health Record Review
- Pirtobrutinib
- Questionnaire Administration
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Jennifer Woyach
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov