OncoMatch/Clinical Trials/NCT06812715
Clonal Dynamics of Chronic Lymphocytic Leukaemia Treated With Pirtobrutinib After Previous Treatment With Zanubrutinib
Is NCT06812715 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pirtobrutinib for chronic lymphocytic leukemia.
Treatment: Pirtobrutinib — This is a multicentre single-arm prospective phase II trial evaluating pirtobrutinib in the treatment of relapsed/refractory (R/R) Chronic Lymphocytic Leukaemia (CLL) patients who have previously received zanubrutinib, and to specifically evaluate Bruton Tyrosine Kinase (BTK) mutational status (clonal dynamics) before, during and after treatment with pirtobrutinib.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BTK inhibitor (zanubrutinib) — most recent prior line
Prior systemic therapy, which must include zanubrutinib as the most recent prior line of therapy. Patients must have received at least one cycle (28 days) of zanubrutinib
Cannot have received: BTK inhibitor (pirtobrutinib)
Prior treatment with pirtobrutinib
Cannot have received: stem cell transplant
Exception: allowed if >60 days prior and no active GVHD, cytopenias, or ongoing immunosuppression
History of allogeneic or autologous stem cell transplant or chimeric antigen receptor T-cell (CAR-T) therapy within the past 60 days and/or with any of the following: Active graft versus host disease, Cytopenias from incomplete blood cell count recovery post-transplant or CAR-T therapy, Need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity Grade > 1 from CAR-T therapy, Ongoing immunosuppressive therapy
Cannot have received: CAR-T cell therapy
Exception: allowed if >60 days prior and no active GVHD, cytopenias, or ongoing immunosuppression
History of allogeneic or autologous stem cell transplant or chimeric antigen receptor T-cell (CAR-T) therapy within the past 60 days and/or with any of the following: Active graft versus host disease, Cytopenias from incomplete blood cell count recovery post-transplant or CAR-T therapy, Need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity Grade > 1 from CAR-T therapy, Ongoing immunosuppressive therapy
Lab requirements
Blood counts
Absolute neutrophil count > 0.75 × 10^9/L (G-CSF support allowed if marrow infiltrated by CLL); Platelets ≥ 30 × 10^9/L independent of transfusions within 7 days; Haemoglobin ≥ 70 g/L independent of transfusions within 7 days
Kidney function
creatinine clearance of > 30 mL/minute calculated by Cockroft-Gault formula or using biochemical or nuclear medicine techniques
Liver function
Total bilirubin ≤ 1.5× ULN or ≤ 3.0 x ULN with documented liver involvement and/or Gilbert's Disease; ALT and AST < 3.0 × ULN or ≤ 5.0 × ULN with documented liver involvement
Cardiac function
QTcF ≤ 470 msec (Fridericia's Formula); Documented left ventricular ejection fraction by any method of > 40% in the 12 months prior to registration
Must have adequate bone marrow function...Normal hepatic function defined as...Adequate renal function defined as...Prolongation of the corrected QT interval using the Fredericia formula (QTcF) > 470 msec [excluded]...Documented left ventricular ejection fraction by any method of ≤ 40% in the 12 months prior to registration [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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