Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer

Sponsor: Loxo Oncology, Inc.

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05172700

Patient View

This expanded access program provides pirtobrutinib, an oral drug, to patients with B-cell cancers like CLL, SLL, MCL, RT, or WM who have undergone specific prior treatments and are ineligible for ongoing trials. Eligibility requires prior treatment with therapies such as chemotherapy, anti-CD20 antibodies, and covalent BTK inhibitors.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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

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You can sign up and apply your patients for this program.