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
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.
Study Type
Expanded Access
Condition
Leukemia, Lymphocytic, Chronic, B-Cell
Intervention
Pirtobrutinib
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
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
Gender
All
Ages
18 Years - N/A
Contacts
Contact Lilly at 1-800-LillyRx (1-800-545-5979), 1-800-LillyRx (1-800-545-5979), [email protected]
Administrative Informations
NCT ID
NCT05172700
Organization ID
17712
Secondary IDs
J2N-OX-Y001
Responsible Party
Sponsor
Study Sponsor
Loxo Oncology, Inc.
Study Sponsor
Contact Lilly at 1-800-LillyRx (1-800-545-5979), Study Director, Eli Lilly and Company
Verification Date
January 15, 2023