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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005843-21 | EudraCT Number | ||
| MOH_2022-08-21_010606 | Registry Identifier | Israel Clinical Research Site | |
| 2023-507041-28 | Other Identifier | EU Trial (CTIS) Number |
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The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-363, KITE-753, KITE-197, and anitocabtagene autoleucel in participants of Kite-sponsored interventional studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axicabtagene Ciloleucel (KTE-C19) | All participants who previously received axicabtagene ciloleucel (KTE-C19) in the parent study will be enrolled in this cohort for long-term follow-up. |
| |
| Brexucabtagene Autoleucel (KTE-X19) | All participants who previously received brexucabtagene autoleucel (KTE-X19) in the parent study will be enrolled in this cohort for long-term follow-up. |
| |
| Anitocabtagene autleucel | All participants who previously received anitocabtagene autleucel in the parent study will be enrolled in this cohort for long-term follow-up. |
| |
| KITE-753 | All participants who previously received KITE-753 in the parent study will be enrolled in this cohort for long-term follow-up. |
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| KITE-197 | All participants who previously received KITE-197 in the parent study will be enrolled in this cohort for long-term follow-up. |
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| KITE-363 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axicabtagene Ciloleucel | Biological | No investigational product will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs) | Targeted AEs include late-onset targeted AEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and new malignancies. | Up to 15 years |
| Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs) | Targeted SAEs include late-onset targeted SAEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and new malignancies. | Up to 15 years |
| Height of Pediatric and Adolescent Participants | Up to 15 years | |
| Weight of Pediatric and Adolescent Participants | Up to 15 years | |
| Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score | The Tanner Pubertal Stage Scale is a measure of pubertal development (sexual maturation) in children and adolescents with components described for each sex, rated separately on a scale of stage one to stage five, with 1 for preadolescent and 5 for mature/adult. | Up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Subsequent Anticancer Therapies | Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs. | Up to 15 years |
| Survival Status Assessment | Survival status will be assessed as the length of time from the participant's first dose date of study drug to death during the study due to any cause or last date of being alive during the study. Survival status will be assessed only per regulatory request or sponsor needs. |
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Inclusion Criteria:
Exclusion Criteria: none
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The participants who received an infusion of gene-modified cells and have not died, withdrawn consent, been withdrawn by the investigator, or been lost to follow-up at the time of transition from the completed parent study.
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| Name | Affiliation | Role |
|---|---|---|
| Kite Study Director | Kite, A Gilead Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| City of Hope |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42036693 | Derived | Munoz J, Locke FL, Reagan PM, Goy A, Jacobson CA, Hill BT, Timmerman JM, Flinn IW, Miklos DB, Pagel JM, Kersten MJ, Forcade E, Topp MS, Houot R, Beitinjaneh A, Zheng D, Chang M, Zhang W, Shen RR, Khalid RD, Kloos I, Wang ML. Five-year follow-up of patients with relapsed/refractory mantle cell lymphoma treated with anti-CD19 CAR T-cell therapy in ZUMA-2, Cohorts 1 and 2. J Hematol Oncol. 2026 Apr 27;19(1):39. doi: 10.1186/s13045-026-01797-4. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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Fresh or archival tumor samples, bone marrow biopsy and/or aspirate and blood draws
All participants who previously received KITE-363 in the parent study will be enrolled in this cohort for long-term follow-up. |
|
| Brexucabtagene Autoleucel | Biological | No investigational product will be administered |
|
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| Anitocabtagene autleucel | Biological | No investigational product will be administered |
|
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| KITE-753 | Biological | No investigational product will be administered |
|
| KITE-197 | Biological | No investigational product will be administered |
|
| KITE-363 | Biological | No investigational product will be administered |
|
| Up to 15 years |
| Percentage of Participants With Cause of Death | Up to 15 years |
| Overall Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) | Up to 15 years |
| Percentage of Participants With Vector Integration Site(s) for Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product | Up to 15 years |
| Percentage of Participants With Status of Primary Malignant Disease | Up to 15 years |
| Duarte |
| California |
| 91010 |
| United States |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Stanford University | Palo Alto | California | 94305 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| University of California, San Francisco Medical Center | San Francisco | California | 94143 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Sylvester Comprehensive Cancer Centre | Miami | Florida | 33136 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Ann& Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| University of Chicago Medical Center Clinical Laboratories | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| The University of Kansas Cancer Center Westwood | Westwood | Kansas | 66205 | United States |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Center Institute | Detroit | Michigan | 48201 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| University of Nebraska | Omaha | Nebraska | 68198 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Ichann School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Mayo Clinic | Rochester | New York | 55905 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| DUHS-Duke Blood Cancer Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| James Cancer Hospital and Solove Research Institute | Columbus | Ohio | 43220 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Prisma Health Cancer Institute | Greenville | South Carolina | 29615 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| St. David's Medical Center | Austin | Texas | 78704 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Sarah Cannon-Methodist Healthcare System - San Antonio | San Antonio | Texas | 78229 | United States |
| Intermountain LDS Hospita;/Blood and Marrow Transplant/ Acute Leukemia Program | Salt Lake City | Utah | 84143 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie | Innsbruck | 6020 | Austria |
| UZ Leuven | Leuven | 3000 | Belgium |
| McGill University Health Center | Montreal | H4A 3J1 | Canada |
| The Ottawa Hospital - General Campus | Ottawa | K1YE9 | Canada |
| Hôpital de l'Enfant-Jésus | Québec | G1J 1Z4 | Canada |
| The hospital for sick children | Toronto | M5G 1X8 | Canada |
| Princess Margaret Cancer Center - University Health Network | Toronto | M5G 2C4 | Canada |
| Vancouver General Hospital | Vancouver | V5Z 1M9 | Canada |
| Centre Hospitalier Regional Universitaire de Lille | Lille | 59037 | France |
| Hospital Saint Eloi | Montpellier | 34295 | France |
| Hopital Saint-Louis | Paris | 75010 | France |
| CHU Bordeaux, Hopital Haut-Leveque | Pessac | 33604 | France |
| Centre Hospitalier Lyon-Sud | Pierre-Bénite | 69495 | France |
| Hôpital Pontchaillou - CHU de Rennes | Rennes | 35033 | France |
| Universitatsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Universittsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Johannes Gutenberg University Hospital-University Mainz | Mainz | 55101 | Germany |
| LMU Klinikum der Universitat Munchen,Med. Klinik und Poliklinik III | München | 81377 | Germany |
| Universitatsklinikum Wurzburg, Med. Klinik und Poliklinik II, Zentrum lnnere Medizin | Würzburg | 97080 | Germany |
| Tel Aviv Souraski Medical Center | Tel Aviv | 6423906 | Israel |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Ospedale Pediatrico Bambino Gesu | Rome | 00165 | Italy |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Hokkaido University Hospital | Sapporo Hokkaido | 060-8648 | Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| Amsterdam Universitair Medische Centra (UMC) | Amsterdam | 1100 | Netherlands |
| University Medical Centre Groningen | Groningen | 9700 RB | Netherlands |
| Radboud Universitair Medisch Centrum | Nijmegen | 6525 GA | Netherlands |
| Erasmus University Medical Centre (MC) | Rotterdam | 3011PL | Netherlands |
| UMC Utrecht | Utrecht | 3508 GA | Netherlands |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Institut Catalia d'Oncologia L'Hospitalet | Barcelona | 08908 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Istituto Oncologico Della Svizzera Italiana (IOSI) | Bellinzona | 6500 | Switzerland |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| The Royal Marsden NHS Foundation Hospital | London | SW10 9NH | United Kingdom |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000629083 | axicabtagene ciloleucel |
| C000705347 | brexucabtagene autoleucel |
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