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| ID | Type | Description | Link |
|---|---|---|---|
| J2N-MC-JZ03 | Other Identifier | Eli Lilly and Company | |
| J2N-MC-JZNY | Other Identifier | Eli Lilly and Company |
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This study will evaluate the long-term safety of pirtobrutinib in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study is open to those who completed J2N-MC-JZNN/LOXO-BTK-20020 (NCT 04666038) for continued access to the study intervention or continued follow-up visits. Treatment will be given every 4 weeks and this study is expected to last about 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirtobrutinib (Arm A) | Experimental | Participants receive pirtobrutinib orally |
|
| Idelalisib (Arm B) | Experimental | Participants receive idelalisib orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirtobrutinib | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with a Grade 3 or Higher Treatment-emergent Adverse Events (AEs) | Time from First Dose of Study Intervention (Study Day 1) through 30 Days After Last Dose of Study Intervention or Start of 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 Enrollment in the Originator Study until Death from Any Cause (Up to 93 Months) |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Mitchell Cancer Institute | Not yet recruiting | Mobile | Alabama | 36693 | 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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| Idelalisib | Drug | Administered orally |
|
| Arizona Oncology Associates, P.C. - HOPE | Not yet recruiting | Tucson | Arizona | 85711 | United States |
|
| Cancer Specialists, LLC | Recruiting | Jacksonville | Florida | 32256 | United States |
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| Minnesota Oncology Hematology, P.A. | Not yet recruiting | Coon Rapids | Minnesota | 55433 | United States |
|
| Cayuga Cancer Center | Not yet recruiting | Ithaca | New York | 14850 | United States |
|
| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York | Recruiting | New York | New York | 10065-6007 | United States |
|
| Oncology Hematology Care Inc | Not yet recruiting | Cincinnati | Ohio | 45211 | United States |
|
| Texas Oncology - Paris | Not yet recruiting | Fort Worth | Texas | 76104 | United States |
|
| US Oncology - Texas Oncology | Not yet recruiting | Kyle | Texas | 78640 | United States |
|
| Liverpool Hospital | Not yet recruiting | Liverpool | 2170 | Australia |
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| The Alfred Hospital | Not yet recruiting | Melbourne | 3004 | Australia |
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| LKH - Universitätsklinikum der PMU Salzburg | Not yet recruiting | Salzburg | 5020 | Austria |
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| AZ Delta | Not yet recruiting | Roeselare | 8800 | Belgium |
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| Princess Margaret Cancer Centre - University Health Network | Not yet recruiting | Toronto | M5G 2M9 | Canada |
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| Xuanwu Hospital Capital Medical University | Not yet recruiting | Beijing | 100053 | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | 410013 | China |
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| Sun Yat-sen University Cancer Center | Not yet recruiting | Guangdong | 510060 | China |
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| Nanfang Hospital of Southern Medical University | Not yet recruiting | Guangzhou | 510515 | China |
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| Gansu Provincial Cancer Hospital | Not yet recruiting | Lanzhou | 730050 | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | 330006 | China |
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| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | 200032 | China |
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| Taizhou Hospital of Zhejiang Province | Not yet recruiting | Taizhou | 317000 | China |
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| Hematology Hospital of the Chinese Academy of Medical Sciences | Not yet recruiting | Tianjin | 300020 | China |
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| Tianjin Medical University Cancer Institute & Hospital | Not yet recruiting | Tianjin | 300060 | China |
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| Affiliated Cancer Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | 830000 | China |
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| The Affiliated Hospital of Xuzhou Medical College | Not yet recruiting | Xuzhou | 221000 | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | 450003 | China |
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| University Hospital Center Zagreb | Not yet recruiting | Zagreb | 10000 | Croatia |
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| Fakultni nemocnice Hradec Kralove | Not yet recruiting | Hradec Králové | 500 05 | Czechia |
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| Centre Henri Becquerel | Not yet recruiting | Rouen | 76038 | France |
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| Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet | Not yet recruiting | Budapest | 1097 | Hungary |
|
| Debreceni Egyetem | Not yet recruiting | Debrecen | 4032 | Hungary |
|
| St. James's Hospital | Not yet recruiting | Dublin | D08 NHY1 | Ireland |
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| Beaumont Hospital | Not yet recruiting | Dublin | DUBLIN 9 | Ireland |
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| Azienda Ospedaliero - Universitaria Nazionale Santi Antonio e Biagio e Cesare Arrigo | Not yet recruiting | Alessandria | 15121 | Italy |
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| Azienda Ospedaliera Universitaria Careggi | Not yet recruiting | Florence | 50134 | Italy |
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| Presidio Ospedaliero Papardo | Not yet recruiting | Messina | 98158 | Italy |
|
| Fondazione IRCCS San Gerardo dei Tintori | Not yet recruiting | Monza | 20900 | Italy |
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| Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia | Not yet recruiting | Perugia | 06129 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Not yet recruiting | Rome | 00138 | Italy |
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| Tel Aviv Sourasky Medical Center | Not yet recruiting | Tel Aviv | 6423906 | Italy |
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| Azienda Ospedaliera S. Maria Di Terni | Not yet recruiting | Terni | 05100 | Italy |
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| Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma | Not yet recruiting | Verona | 37134 | Italy |
|
| Tokai University Hospital | Recruiting | Isehara | 259-1193 | Japan |
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| Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza | Not yet recruiting | Brzozów | 36-200 | Poland |
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| Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy | Not yet recruiting | Bydgoszcz | 85-168 | Poland |
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| Pratia Onkologia Katowice | Not yet recruiting | Katowice | 40-519 | Poland |
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| Instytut Hermatologii I Transfuzjologii | Not yet recruiting | Warsaw | 02-776 | Poland |
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| Hospital Universitario Marques De Valdecilla | Not yet recruiting | Santander | 39008 | Spain |
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| Hospital Universitario Virgen Del Rocio | Not yet recruiting | Seville | 41010 | Spain |
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| Castle Hill Hospital | Not yet recruiting | Hull | HU16 5JQ | United Kingdom |
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| St James's University Hospital | Recruiting | Leeds | LS9 7TF | United Kingdom |
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| GenesisCare | Not yet recruiting | Newmarket | CB8 7XN | United Kingdom |
|
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| 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 |
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| ID | Term |
|---|---|
| C000723100 | pirtobrutinib |
| C552946 | idelalisib |
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