search
Back to results

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

Primary Purpose

Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Lymphocytic, Small, Lymphoma, Mantle-Cell

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Pirtobrutinib
Sponsored by
Loxo Oncology, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Leukemia, Lymphocytic, Chronic, B-Cell focused on measuring BTKi, BTK Inhibitor, Bruton's tyrosine kinase inhibitor, Hematologic Disease, B-cell receptor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 15, 2021
    Last Updated
    October 19, 2023
    Sponsor
    Loxo Oncology, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05172700
    Brief Title
    Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer
    Official Title
    Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    October 15, 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Loxo Oncology, Inc.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Pirtobrutinib
    Other Intervention Name(s)
    LY3527727, LOXO-305
    Intervention Description
    Administered orally.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    In the U.S., physicians seeking help on behalf of their patients may contact Lilly at
    Phone
    1-800-LillyRx (1-800-545-5979)
    Email
    Clinicaltrials.gov@lilly.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Contact Lilly at 1-800-LillyRx (1-800-545-5979)
    Organizational Affiliation
    Eli Lilly and Company
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs