Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Обзор

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.

Вмешательства

• Биопрепарат Axicabtagene Ciloleucel
  No investigational product will be administered
• Биопрепарат Brexucabtagene Autoleucel
  No investigational product will be administered
• Биопрепарат Anitocabtagene autleucel
  No investigational product will be administered
• Биопрепарат KITE-753
  No investigational product will be administered
• Биопрепарат KITE-197
  No investigational product will be administered
• Биопрепарат KITE-363
  No investigational product will be administered

Первичные конечные точки

• Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs) [Срок оценки: Up to 15 years]
• Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs) [Срок оценки: Up to 15 years]
• Height of Pediatric and Adolescent Participants [Срок оценки: Up to 15 years]
• Weight of Pediatric and Adolescent Participants [Срок оценки: Up to 15 years]
• Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score [Срок оценки: Up to 15 years]

Вторичные конечные точки (6)

• Time to Subsequent Anticancer Therapies [Срок оценки: Up to 15 years]
• Survival Status Assessment [Срок оценки: Up to 15 years]
• Percentage of Participants With Cause of Death [Срок оценки: Up to 15 years]
• Overall Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) [Срок оценки: 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 [Срок оценки: Up to 15 years]
• Percentage of Participants With Status of Primary Malignant Disease [Срок оценки: Up to 15 years]

Критерии участия

Критерии включения

• The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable
• The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted
• In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation

Exclusion Criteria: none

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 49 центров

• Banner MD Anderson Cancer Center — Gilbert
• City of Hope — Duarte
• UC San Diego Moores Cancer Center — La Jolla
• Children's Hospital Los Angeles — Los Angeles
• University of California Los Angeles — Los Angeles
• Children's Hospital of Orange County — Orange
• Stanford University — Palo Alto
• University of California Davis Comprehensive Cancer Center — Sacramento
• … и ещё 41 центр

Канада · 6 центров

• McGill University Health Center — Montreal
• The Ottawa Hospital - General Campus — Ottawa
• Hôpital de l'Enfant-Jésus — Québec
• The hospital for sick children — Toronto
• Princess Margaret Cancer Center - University Health Network — Toronto
• Vancouver General Hospital — Vancouver

Франция · 6 центров

• Centre Hospitalier Regional Universitaire de Lille — Lille
• Hospital Saint Eloi — Montpellier
• Hopital Saint-Louis — Paris
• CHU Bordeaux, Hopital Haut-Leveque — Pessac
• Centre Hospitalier Lyon-Sud — Pierre-Bénite
• Hôpital Pontchaillou - CHU de Rennes — Rennes

Германия · 6 центров

• Universitatsklinikum Carl Gustav Carus — Dresden
• Universitätsklinikum Hamburg-Eppendorf — Hamburg
• Universittsklinikum Heidelberg — Heidelberg
• Johannes Gutenberg University Hospital-University Mainz — Mainz
• LMU Klinikum der Universitat Munchen,Med. Klinik und Poliklinik III — München
• Universitatsklinikum Wurzburg, Med. Klinik und Poliklinik II, Zentrum lnnere Medizin — Würzburg

Япония · 5 центров

• Kyushu University Hospital — Fukuoka
• Kyoto University Hospital — Kyoto
• Okayama University Hospital — Okayama
• Hokkaido University Hospital — Sapporo Hokkaido
• National Cancer Center Hospital — Tokyo

Нидерланды · 5 центров

• Amsterdam Universitair Medische Centra (UMC) — Amsterdam
• University Medical Centre Groningen — Groningen
• … и ещё 3 центра

Испания · 4 центра

Список центров уточняется — проверьте первичный протокол.

Италия · 2 центра

• ASST Grande Ospedale Metropolitano Niguarda — Milan
• Ospedale Pediatrico Bambino Gesu — Rome

Великобритания · 2 центра

Список центров уточняется — проверьте первичный протокол.

Австралия · 1 центр

• Peter MacCallum Cancer Centre — Melbourne

Австрия · 1 центр

• Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie — Innsbruck

Бельгия · 1 центр

• UZ Leuven — Leuven

Израиль · 1 центр

• Tel Aviv Souraski Medical Center — Tel Aviv

Швейцария · 1 центр

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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 2 PMID 42036693

Идентификаторы

NCT: NCT05041309 · KT-US-982-5968 · 2020-005843-21 · MOH_2022-08-21_010606 · 2023-507041-28

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗