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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517760-29-00 | EU Trial (CTIS) Number | ||
| J2N-MC-JZNY | Other Identifier | Eli Lilly and Company | |
| J2N-MC-JZ01 | Other Identifier | Eli Lilly and Company | |
| J2N-MC-JZ02 | Other Identifier | Eli Lilly and Company | |
| J2N-MC-JZ03 | Other Identifier | Eli Lilly and Company |
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The master protocol study J2N-MC-JZNY provides a framework to enable the evaluation of the long-term safety and efficacy of pirtobrutinib after completion of clinical studies evaluating pirtobrutinib. The clinical studies that will feed into this master protocol are referred to as originator studies. The master protocol will govern individual study-specific appendices (ISAs) that will represent participants from the individual, completed originator studies. These participants will have the opportunity to enter this study and continue to receive treatment or continue follow-up visits. Overall, the master protocol and the individual ISAs, when combined, define the investigations for this study.
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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. |
|
| 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 AEs | 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 randomization in a randomized Originator study, or from the first dose in a non-randomized Originator study, until death from any cause. | Time from randomization in a randomized Originator study, or from the first dose in a non-randomized Originator study, until death from any cause (Up to 93 Months) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria are defined in each ISA.
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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 |
|---|---|---|---|---|---|---|
| Cancer Specialists, LLC | Not yet recruiting | Jacksonville | Florida | 32256 | 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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| Sylvester Comprehensive Cancer Center | Recruiting | Miami | Florida | 33136-1002 | United States |
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| Florida Cancer Specialists | Recruiting | Sarasota | Florida | 34232-6422 | United States |
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| The Emory Clinic | Not yet recruiting | Atlanta | Georgia | 30322-1013 | United States |
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| Northwestern University | Not yet recruiting | Chicago | Illinois | 60611-3013 | United States |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | 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 | Recruiting | Ithaca | New York | 14850 | United States |
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| 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 | Not yet recruiting | New York | New York | 10065-6007 | United States |
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| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York | Not yet recruiting | New York | New York | 10065-6007 | United States |
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| 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 | 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 | Recruiting | Melbourne | 3000 | Australia |
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| Linear Clinical Research | Recruiting | Victoria | 3000 | Australia |
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| CHU de Nantes - Hotel Dieu | Recruiting | Nantes | 44093 | France |
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| IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi | Recruiting | Bologna | 40138 | Italy |
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| Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
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| Nagoya Medical Center | Recruiting | Aichi-Ken | 4600001 | Japan |
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| National Cancer Center Hospital | Recruiting | Cho-ku | 104-0045 | Japan |
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| National Hospital Organization Kyushu Cancer Center | Recruiting | Fukuoka | 811-1395 | Japan |
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| Tokai University Hospital- Isehara Campus | Recruiting | Isehara | 259-1193 | Japan |
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| Tohoku University Hospital | Recruiting | Miyagi-Ken | 9808574 | Japan |
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| Hokkaido University Hospital | Recruiting | Sapporo | 060-8648 | Japan |
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| Pratia MCM Krakow | Recruiting | Krakow | 30727 | Poland |
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| Instytut Hermatologii I Transfuzjologii | Recruiting | Warsaw | 02776 | 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 | Not yet 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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