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
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
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
NCT ID
NCT05172700
First Posted
December 15, 2021
Last Updated
October 19, 2023
Sponsor
Loxo Oncology, Inc.
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