Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer

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ClinicalTrials.gov Identifier: NCT05172700

Expanded Access Status : Available

First Posted : December 29, 2021

Last Update Posted : October 23, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company ( Loxo Oncology, Inc. )

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.

Condition or disease	Intervention/treatment
Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Lymphocytic, Small Lymphoma, Mantle-Cell Waldenstrom Macroglobulinemia Ritcher's Transformation, Syndrome	Drug: Pirtobrutinib

Study Design

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Study Type :	Expanded Access
Expanded Access Type :	Individual Patients
	See clinical trials of the intervention/treatment in this expanded access record.
Official Title:	Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Waldenström macroglobulinemia

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease Lymphosarcoma Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Waldenstrom Macroglobulinemia

U.S. FDA: Expanded Access (Compassionate Use)

U.S. FDA Resources

Interventions

Intervention Details:

Drug: Pirtobrutinib
Administered orally.
Other Names:
- LY3527727
- LOXO-305

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05172700

Contacts

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Contact: In the U.S., physicians seeking help on behalf of their patients may contact Lilly at	1-800-LillyRx (1-800-545-5979)	Clinicaltrials.gov@lilly.com

Sponsors and Collaborators

Loxo Oncology, Inc.

Investigators

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Study Director:	Contact Lilly at 1-800-LillyRx (1-800-545-5979)	Eli Lilly and Company

More Information

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Responsible Party:	Loxo Oncology, Inc.
ClinicalTrials.gov Identifier:	NCT05172700
Other Study ID Numbers:	17712 J2N-OX-Y001 ( Other Identifier: Eli Lilly and Company )
First Posted:	December 29, 2021 Key Record Dates
Last Update Posted:	October 23, 2023
Last Verified:	October 15, 2023

Keywords provided by Eli Lilly and Company ( Loxo Oncology, Inc. ):


BTKi BTK Inhibitor Bruton's tyrosine kinase inhibitor Hematologic Disease B-cell receptor

Additional relevant MeSH terms:

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Lymphoma Waldenstrom Macroglobulinemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases	Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Leukemia Leukemia, B-Cell Chronic Disease Disease Attributes Pathologic Processes Lymphoma, Non-Hodgkin Pirtobrutinib Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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