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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517760-29-00 | EU Trial (CTIS) Number | ||
| J2N-MC-JZ01 | Other Identifier | Eli Lilly and Company | |
| J2N-MC-JZNY | Other Identifier | Eli Lilly and Company |
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Study J2N-MC-JZ01 (JZ01) is an individual-study appendix (ISA) under master protocol J2N-MC-JZNY, and represents participants from the completed originator study, clinical study LOXO-BTK-18001/J2N-OX-JZNA. Participants in the originator study will have the opportunity to continue their assigned study intervention or continue their follow-up visits by transitioning to this study. This study will evaluate the long-term safety and efficacy of pirtobrutinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JZ01 Pirtobrutinib | Experimental | Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA). Pirtobrutinib administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirtobrutinib | Drug | Administered orally. |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with a Grade ≥3 treatment-emergent adverse events (TEAEs) | Time from the Date of the First Dose of Study Intervention (Study Day 1) through 30 Days (+ 7-day window) After the Date of the Last Dose of Study Intervention or The First Date Starting a New Anticancer Therapy, whichever is Earlier |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival is defined as the time from enrollment from the originator study until death from any cause | Time from Enrollment from the Originator Study until Death from Any Cause (Up to 93 Months) |
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Inclusion Criteria:
Are currently enrolled and active in the originator study, LOXO-BTK-18001. A participant is considered active in the study if they are:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sylvester Comprehensive Cancer Center | Recruiting | Miami | Florida | 33136-1002 | United States |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Florida Cancer Specialists | Recruiting | Sarasota | Florida | 34232-6422 | United States |
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| The Emory Clinic | Recruiting | Atlanta | Georgia | 30322-1013 | United States |
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| Northwestern University | Recruiting | Chicago | Illinois | 60611-3013 | United States |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Mayo Clinic- Minnesota | Recruiting | Rochester | Minnesota | 55905 | United States |
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| University Of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 69198 | United States |
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| Cayuga Cancer Center | Active, not recruiting | Ithaca | New York | 14850 | United States |
| Northwell Health | Recruiting | Lake Success | New York | 11042-1118 | United States |
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| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York | Recruiting | New York | New York | 10065-6007 | United States |
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| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York | Active, not recruiting | New York | New York | 10065-6007 | United States |
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710-4000 | United States |
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| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210-1063 | United States |
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| University of Pennsylvania Hospital | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Tennessee Oncology | Recruiting | Nashville | Tennessee | 37203-2659 | United States |
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| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030-4000 | United States |
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| Swedish Cancer Institute | Recruiting | Seattle | Washington | 98104-3588 | United States |
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| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226-3548 | United States |
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| Flinders Medical Centre | Recruiting | Adelaide | 5042 | Australia |
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| Peter MacCallum Cancer Centre | Completed | Melbourne | 3000 | Australia |
| Linear Clinical Research | Active, not recruiting | Victoria | 3000 | Australia |
| CHU de Nantes - Hotel Dieu | Recruiting | Nantes | 44093 | France |
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| IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi | Completed | Bologna | 40138 | Italy |
| Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
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| Nagoya Medical Center | Active, not recruiting | Aichi-Ken | 4600001 | Japan |
| National Cancer Center Hospital | Completed | Cho-ku | 104-0045 | Japan |
| National Hospital Organization Kyushu Cancer Center | Active, not recruiting | Fukuoka | 811-1395 | Japan |
| Tokai University Hospital- Isehara Campus | Active, not recruiting | Isehara | 259-1193 | Japan |
| Tohoku University Hospital | Active, not recruiting | Miyagi-Ken | 9808574 | Japan |
| Hokkaido University Hospital | Active, not recruiting | Sapporo | 060-8648 | Japan |
| Pratia MCM Krakow | Recruiting | Krakow | 30727 | Poland |
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| Instytut Hermatologii I Transfuzjologii | Recruiting | Warsaw | 02-776 | Poland |
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| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| St James's University Hospital | Recruiting | Leeds | LS9 7TF | United Kingdom |
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| Churchill Hospital | Recruiting | Oxford | OX3 7LE | United Kingdom |
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| Derriford Hospital | Recruiting | Plymouth | PL6 8DH | United Kingdom |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| C000723100 | pirtobrutinib |
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