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

Last updated: December 13, 2024
Sponsor: Loxo Oncology, Inc.
Overall Status: Planned

Phase

N/A

Condition

Lymphoma

Lymphocytic Leukemia, Chronic

Waldenstrom Macroglobulinemia

Treatment

Pirtobrutinib

Clinical Study ID

NCT05172700
17712
J2N-OX-Y001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have been diagnosed with:

  • CLL or SLL and have received treatment with the following five classes oftherapy: 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

Exclusion Criteria:

  • Inadequate organ function

  • Significant cardiovascular disease

  • History of allogenic or autologous stem cell transplant (SCT) or chimeric antigenreceptor modified Tcell (CAR-T) therapy within 60 days

  • Tested positive for human immunodeficiency syndrome (HIV) or known active hepatitisB or C virus or cytomegalovirus (CMV) infection

  • Active, uncontrolled autoimmune cytopenia

  • Clinically significant active malabsorption syndrome

  • Participants requiring therapeutic anticoagulation with warfarin or another vitaminK antagonist

Study Design

Treatment Group(s): 1
Primary Treatment: Pirtobrutinib
Phase:
Study Start date:
Estimated Completion Date:

Connect with a study center

  • Western Cancer Centre

    Dubbo, New South Wales 2830
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Perth, Western Australia 6003
    Australia

    Site Not Available

  • UZ Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • AZ St Jan Brugge Oostende AV

    Brugge, 8000
    Belgium

    Site Not Available

  • University Hospital Cologne

    Cologne, NRW 50937
    Germany

    Site Not Available

  • Universitätsmedizin Göttingen

    Göttingen, Niedersachsen 37075
    Germany

    Site Not Available

  • Second Medical Department, University Hospital Schleswig-Holstein

    Kiel, Schleswig-Holstein 25259
    Germany

    Site Not Available

  • Charité-Campus Benjamin Franklin-Hematology and Oncology

    Berlin, 12203
    Germany

    Site Not Available

  • University Hospital Galway

    Galway, H91 YR71
    Ireland

    Site Not Available

  • Bnai Zion Medical Center

    Haifa, 3339419
    Israel

    Site Not Available

  • Beilinson Hospital

    Petah Tikva,
    Israel

    Site Not Available

  • Rijnstate Arnhem

    Arnhem, Gelderland 6815 AD
    Netherlands

    Site Not Available

  • Karolinska University Hospital, ME Hematologi

    Stockholm, SE-17176
    Sweden

    Site Not Available

  • University Hospital Crosshouse

    Crosshouse, Ayrshire KA2QBE
    United Kingdom

    Site Not Available

  • Royal Cornwall Hospital

    Truro, Cornwall TR1 3LJ
    United Kingdom

    Site Not Available

  • Cumberland Infirmary

    Carlisle, Cumbria CA2 7HY
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth, Devon PL6 8DH
    United Kingdom

    Site Not Available

  • Eastbourne District General Hospiatl

    Eastbourne, E.susx BN21 2UD
    United Kingdom

    Site Not Available

  • Arrowe Park Hospital

    Wirral, Merseyside L49 5LN
    United Kingdom

    Site Not Available

  • Nottingham City Hospital

    Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

    Site Not Available

  • Dumfries & Galloway Royal Infirmary

    Dumfries, Scotland DG2 8RX
    United Kingdom

    Site Not Available

  • NCCC, Freeman Hospital

    Newcastle upon Tyne, Tyne And Wear NE7 7DN
    United Kingdom

    Site Not Available

  • Royal United Hospital

    Bath, BA1 3NG
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • Stanford University Hospital

    Stanford, California 94305-5208
    United States

    Site Not Available

  • Rocky Mountain Cancer Center

    Boulder, Colorado 80303
    United States

    Site Not Available

  • Memorial Healthcare System

    Pembroke Pines, Florida 33316
    United States

    Site Not Available

  • Florida Cancer Specialists

    Trinity, Florida 34655
    United States

    Site Not Available

  • University of Chicago Hospital

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Universtiy of Kansas Cancer Center

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • University of Minnesota Hospital

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Logan Health Research

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Community Medical Center

    Missoula, Montana 59804
    United States

    Site Not Available

  • Medical Diagnostic Associates at Carol G. Simon Cancer Center Overlook Medical Center

    Summit, New Jersey 07901
    United States

    Site Not Available

  • Northwell Health/CLL Research and Treatment Program

    New Hyde Park, New York 11563
    United States

    Site Not Available

  • Memorial Sloan Kettering

    New York, New York 10021
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Novant Health Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Willamette Valley Cancer Institute

    Eugene, Oregon 97401
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232-1305
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • PeaceHealth St Joseph Cancer Ctr

    Bellingham, Washington 98225
    United States

    Site Not Available

  • Kaiser Permanente WA Capitol Hill

    Seattle, Washington 98112
    United States

    Site Not Available

  • American Oncology Network

    Spokane, Washington 99208
    United States

    Site Not Available

  • Summit Cancer Center

    Spokane Valley, Washington 99216
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53590
    United States

    Site Not Available

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