Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Lymphocytic, Small, Lymphoma, Mantle-Cell, Ritcher's Transformation, Syndrome, Waldenstrom Macroglobulinemia
Conditions
Keywords
BTKi, BTK Inhibitor, Bruton's tyrosine kinase inhibitor, Hematologic Disease, B-cell receptor
Brief summary
This is an expanded access program for eligible participants with a previously treated B-cell cancer who are ineligible for an ongoing pirtobrutinib clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
Interventions
DRUGPirtobrutinib
Administered orally.
Sponsors
Loxo Oncology, Inc.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Have been diagnosed with: * CLL or SLL and have received treatment with the following five classes of therapy: Chemotherapy, anti-cluster of differentiation (anti-cd) 20 antibody, covalent Bruton's tyrosine kinase (BTK) inhibitor, B-cell lymphoma-2 (BCL-2) inhibitor, and phosphatidylinositol 3-kinase (PI3K) inhibitor * MCL that has been previously treated with a covalent BTK inhibitor * Richter's Transformation (RT) with previous Richter's directed-therapy * Waldenstrom macroglobulinemia (WM), previously treated with chemotherapy, anti-CD20 antibody and a covalent BTK inhibitor * Are not eligible for an ongoing pirtobrutinib clinical trial
Exclusion criteria
* Inadequate organ function * Significant cardiovascular disease * History of allogenic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified Tcell (CAR-T) therapy within 60 days * Tested positive for human immunodeficiency syndrome (HIV) or known active hepatitis B or C virus or cytomegalovirus (CMV) infection * Active, uncontrolled autoimmune cytopenia * Clinically significant active malabsorption syndrome * Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist
Outcome results
None listed