OncoMatch/Clinical Trials/NCT07685717
Pirtobrutinib for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia
Is NCT07685717 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies Pirtobrutinib for chronic lymphocytic leukemia/small lymphocytic lymphoma.
Treatment: Pirtobrutinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Performance status
ECOG 0–3(Limited self-care)
Demographics
Prior therapy
Cannot have received: chemotherapy for CLL
Exception: palliative loco-regional radiotherapy allowed; 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
Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of palliative loco-regional radiotherapy
Cannot have received: immunotherapy for CLL
Exception: rituximab for autoimmune conditions allowed with 2-week washout prior to study enrollment; corticosteroids for symptom control allowed
Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of rituximab for autoimmune conditions or corticosteroids for symptoms control
Cannot have received: targeted therapy for CLL
Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL
Lab requirements
Blood counts
ANC ≥ 0.75 x 10^9 (on or within 7 days of C1D1 before treatment); patient may enroll below threshold if there is documented bone marrow involvement of CLL considered to impair hematopoiesis. Platelet count ≥ 30 x 10^9 not requiring transfusion support (on or within 7 days of C1D1 before treatment); patient may enroll below threshold if there is documented bone marrow involvement of CLL considered to impair hematopoiesis. Hemoglobin ≥ 6 mg/dL not requiring transfusion support or growth factors (on or within 7 days of C1D1 before treatment); patient may enroll below threshold if there is documented bone marrow involvement of CLL considered to impair hematopoiesis. If patients require transfusion support due to bone marrow involvement of CLL, they must be responsive to transfusion support.
Kidney function
Creatinine clearance ≥ 30 mL/minute using Cockcroft-Gault formula
Liver function
AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy; total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN with documented liver involvement and/or Gilbert's syndrome
Cardiac function
aPTT/PTT and PT/INR not greater than 2.0 × ULN; LVEF > 40% in prior 12 months; QTcF ≤ 470 msec
AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy; total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN with documented liver involvement and/or Gilbert's syndrome; Creatinine clearance ≥ 30 mL/minute using Cockcroft-Gault formula; aPTT/PTT and PT/INR not greater than 2.0 × ULN; ANC ≥ 0.75 x 10^9; Platelet count ≥ 30 x 10^9; Hemoglobin ≥ 6 mg/dL; LVEF > 40% in prior 12 months; QTcF ≤ 470 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07685717 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify