Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer
December 13, 2024 updated by: Loxo Oncology, Inc.
Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers
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 Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979), Eli Lilly and Company
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 7, 2022
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
December 15, 2021
First Submitted That Met QC Criteria
December 15, 2021
First Posted (Actual)
December 29, 2021
Study Record Updates
Last Update Posted (Actual)
December 18, 2024
Last Update Submitted That Met QC Criteria
December 13, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Neoplasms
- Chronic Disease
- Disease Attributes
- Immune System Diseases
- Neoplasms by Histologic Type
- Disease
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Leukemia, B-Cell
- Lymphoma
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Leukemia, Lymphoid
- Leukemia
- Pathological Conditions, Signs and Symptoms
- Hemic and Lymphatic Diseases
- Syndrome
- Leukemia, Lymphocytic, Chronic, B-Cell
- Hematologic Diseases
- Lymphoma, Mantle-Cell
- Waldenstrom Macroglobulinemia
- Tyrosine Kinase Inhibitors
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- pirtobrutinib
Other Study ID Numbers
- 17712
- J2N-OX-Y001 (Other Identifier: Eli Lilly and Company)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.