Studies
| Study First Submitted Date | 2021-12-15 |
| Study First Posted Date | 2021-12-29 |
| Last Update Posted Date | 2023-01-20 |
| Verification Month Year | January 15, 2023 |
| Verification Date | 2023-01-15 |
| Last Update Posted Date | 2023-01-20 |
Browse Interventions
| Sequence: | 96054927 | Sequence: | 96054928 | Sequence: | 96054929 | Sequence: | 96054930 |
| Mesh Term | Pirtobrutinib | Mesh Term | Protein Kinase Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
| Downcase Mesh Term | pirtobrutinib | Downcase Mesh Term | protein kinase inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52174355 | Sequence: | 52174356 | Sequence: | 52174357 | Sequence: | 52174358 | Sequence: | 52174359 |
| Name | Leukemia, Lymphocytic, Chronic, B-Cell | Name | Lymphoma, Lymphocytic, Small | Name | Lymphoma, Mantle-Cell | Name | Waldenstrom Macroglobulinemia | Name | Ritcher's Transformation, Syndrome |
| Downcase Name | leukemia, lymphocytic, chronic, b-cell | Downcase Name | lymphoma, lymphocytic, small | Downcase Name | lymphoma, mantle-cell | Downcase Name | waldenstrom macroglobulinemia | Downcase Name | ritcher's transformation, syndrome |
Id Information
| Sequence: | 40160705 | Sequence: | 40160706 |
| Id Source | org_study_id | Id Source | secondary_id |
| Id Value | 17712 | Id Value | J2N-OX-Y001 |
| Id Type | Other Identifier | ||
| Id Type Description | Eli Lilly and Company | ||
Countries
| Sequence: | 42571107 | Sequence: | 42571108 | Sequence: | 42571109 | Sequence: | 42571110 | Sequence: | 42571111 | Sequence: | 42571112 | Sequence: | 42571113 | Sequence: | 42571114 | Sequence: | 42571115 |
| Name | Australia | Name | Belgium | Name | Germany | Name | Ireland | Name | Israel | Name | Netherlands | Name | Sweden | Name | United Kingdom | Name | United States |
| Removed | True | Removed | True | Removed | True | Removed | True | Removed | True | Removed | True | Removed | True | Removed | True | Removed | True |
Interventions
| Sequence: | 52488401 |
| Intervention Type | Drug |
| Name | Pirtobrutinib |
| Description | Administered orally. |
Keywords
| Sequence: | 79872572 | Sequence: | 79872573 | Sequence: | 79872574 | Sequence: | 79872575 | Sequence: | 79872576 |
| Name | BTKi | Name | BTK Inhibitor | Name | Bruton's tyrosine kinase inhibitor | Name | Hematologic Disease | Name | B-cell receptor |
| Downcase Name | btki | Downcase Name | btk inhibitor | Downcase Name | bruton's tyrosine kinase inhibitor | Downcase Name | hematologic disease | Downcase Name | b-cell receptor |
Browse Conditions
| Sequence: | 193498509 | Sequence: | 193498510 | Sequence: | 193498511 | Sequence: | 193498512 | Sequence: | 193498513 | Sequence: | 193498514 | Sequence: | 193498515 | Sequence: | 193498516 | Sequence: | 193498517 | Sequence: | 193498518 | Sequence: | 193498519 | Sequence: | 193498520 | Sequence: | 193498521 | Sequence: | 193498522 | Sequence: | 193498523 | Sequence: | 193498524 | Sequence: | 193498525 | Sequence: | 193498526 | Sequence: | 193498527 | Sequence: | 193498528 | Sequence: | 193498529 | Sequence: | 193498530 | Sequence: | 193498531 | Sequence: | 193498532 | Sequence: | 193498533 |
| Mesh Term | Lymphoma | Mesh Term | Waldenstrom Macroglobulinemia | Mesh Term | Leukemia, Lymphoid | Mesh Term | Leukemia, Lymphocytic, Chronic, B-Cell | Mesh Term | Lymphoma, Mantle-Cell | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Lymphatic Diseases | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases | Mesh Term | Neoplasms, Plasma Cell | Mesh Term | Hemostatic Disorders | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Paraproteinemias | Mesh Term | Blood Protein Disorders | Mesh Term | Hematologic Diseases | Mesh Term | Hemorrhagic Disorders | Mesh Term | Leukemia | Mesh Term | Leukemia, B-Cell | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Lymphoma, Non-Hodgkin |
| Downcase Mesh Term | lymphoma | Downcase Mesh Term | waldenstrom macroglobulinemia | Downcase Mesh Term | leukemia, lymphoid | Downcase Mesh Term | leukemia, lymphocytic, chronic, b-cell | Downcase Mesh Term | lymphoma, mantle-cell | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | lymphatic diseases | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | neoplasms, plasma cell | Downcase Mesh Term | hemostatic disorders | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | paraproteinemias | Downcase Mesh Term | blood protein disorders | Downcase Mesh Term | hematologic diseases | Downcase Mesh Term | hemorrhagic disorders | Downcase Mesh Term | leukemia | Downcase Mesh Term | leukemia, b-cell | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | lymphoma, non-hodgkin |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48322018 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Loxo Oncology, Inc. |
Overall Officials
| Sequence: | 29286854 |
| Role | Study Director |
| Name | Contact Lilly at 1-800-LillyRx (1-800-545-5979) |
| Affiliation | Eli Lilly and Company |
Central Contacts
| Sequence: | 12009683 |
| Contact Type | primary |
| Name | In the U.S., physicians seeking help on behalf of their patients may contact Lilly at |
| Phone | 1-800-LillyRx (1-800-545-5979) |
| Clinicaltrials.gov@lilly.com | |
| Role | Contact |
Eligibilities
| Sequence: | 30767067 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| 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 |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253922225 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
Intervention Other Names
| Sequence: | 26675016 | Sequence: | 26675017 |
| Intervention Id | 52488401 | Intervention Id | 52488401 |
| Name | LY3527727 | Name | LOXO-305 |
Responsible Parties
| Sequence: | 28879529 |
| Responsible Party Type | Sponsor |