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

• Conditions: Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Lymphocytic, Small; Lymphoma, Mantle-Cell; Waldenstrom Macroglobulinemia; Ritcher's Transformation, Syndrome

• Registration Number: NCT05172700
• Lead Sponsor: Loxo Oncology, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2021-12-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified