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

NCT05172700 | Unknown

• 2 other identifiers: 17712J2N-OX-Y001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

BTKi; BTK Inhibitor; Bruton's tyrosine kinase inhibitor; Hematologic Disease; B-cell receptor

Interventions

Pirtobrutinib DRUG

Administered orally.

Also known as: LY3527727, LOXO-305

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loxo Oncology, Inc.: lead

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Waldenstrom Macroglobulinemia; Syndrome; Hematologic Diseases

Interventions

pirtobrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Disease

Study Officials

• Contact Lilly at 1-800-LillyRx (1-800-545-5979)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: December 29, 2021
• Last Updated: December 18, 2024

Record last verified: 2024-12