Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer
NCT ID: NCT05172700
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
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Detailed Description
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Conditions
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Interventions
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Pirtobrutinib
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Loxo Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Contact Lilly at 1-800-LillyRx (1-800-545-5979)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Other Identifiers
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J2N-OX-Y001
Identifier Type: OTHER
Identifier Source: secondary_id
17712
Identifier Type: -
Identifier Source: org_study_id
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