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Clinical Trials/NCT05172700
NCT05172700Approved For MarketingNot Applicable

Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers

Loxo Oncology, Inc.0 sitesStarted: December 29, 2021Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Approved For Marketing
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Expanded Access

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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