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Набор по приглашению NCT06788509

A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

Фаза I С лечением Leukemia, Myeloid, Acute Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Non-Hodgkin Myelodysplastic Syndromes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: JNJ-75348780, JNJ-67856633, JNJ-54179060, JNJ-64264681.
Кому может быть актуально
Состояния в реестре: Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Австралия, Бельгия, Франция, Грузия, Греция +9
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

An Open Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring

Обзор

The purpose of this study is to collect long-term safety data in participants with cancers including acute myeloid leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome, chronic lymphocytic leukemia (type of cancer of the blood and bone marrow in which the bone marrow makes a large number of abnormal blood cells) and advanced solid tumors and metastatic castration-resistant prostate cancer (mCRPC).

Вмешательства

  • Препарат JNJ-75348780
    Participants from the parent study (75348780LYM1001 \[NCT04540796\]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-75348780.
  • Препарат JNJ-67856633
    Participants from the parent studies (64264681LYM1002 \[NCT04657224\], 67856633LYM1002 \[NCT04876092\] and 67856633LYM1001 \[NCT03900598\]) who are deriving benefit from study treatment will continue to receive JNJ-67856633 orally.
  • Препарат JNJ-54179060
    Participants from the parent study (67856633LYM1002 \[NCT04876092\]) who are deriving benefit from study treatment will continue to receive JNJ-54179060 orally.
  • Препарат JNJ-64264681
    Participants from the parent studies (64264681LYM1001 \[NCT04210219\], 64264681LYM1002 \[NCT04657224\]) who are deriving benefit from study treatment will continue to receive JNJ-64264681 orally.
  • Препарат JNJ-74856665
    Participants from the parent study (74856665AML1001 \[NCT04609826\]) who are deriving benefit from study treatment will continue to receive JNJ-74856665 orally.
  • Препарат JNJ-70218902
    Participants from the parent study (70218902EDI1001 \[NCT04397276\]) who are deriving benefit from study treatment will continue to receive JNJ-70218902 orally.
  • Препарат JNJ-64619178
    Participants from the parent study (64619178EDI1001 \[NCT03573310\]) who are deriving benefit from study treatment will continue to receive JNJ-64619178 orally.
  • Препарат JNJ-80948543
    Participants from the parent studies (80948543LYM1001 \[NCT05424822\]; and 80948543LYM1002 \[NCT06660563\]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-80948543.
  • Препарат JNJ-87801493
    Participants from the parent study (87801493LYM1001 \[NCT06139406\]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-87801493 in combination with subcutaneous JNJ-80948543.

Первичные конечные точки

  • Number of Participants with Serious Adverse Events (SAEs) and Grade Greater than or equals to (>=) 3 Related Adverse Events (AEs) [Срок оценки: Up to approximately 3 years and 7 months]

Критерии участия

Критерии включения

  • Have participated in a parent study, with a linked intervention specific appendix (ISA) within this platform study, in which they initially received study treatment(s) prior to rolling over to this platform study
  • Satisfy all ISA specific inclusion criteria
  • Sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the platform study with details per the relevant ISA
  • Be willing and able to adhere to the lifestyle restrictions specified in the relevant ISA

Критерии исключения

  • Have any condition or situation which, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study
  • Have unacceptable toxicities or overt disease progression observed at time of rollover to the respective ISA
  • Meets any exclusion criteria within the pertinent ISA

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Испания · 7 центров
  • Hosp Univ Vall D Hebron 1 — Barcelona
  • Hosp Univ Vall D Hebron — Barcelona
  • Hosp. Clinic de Barcelona — Barcelona
  • Hosp Univ Fund Jimenez Diaz — Madrid
  • Hosp. Univ. 12 de Octubre — Madrid
  • Clinica Univ. de Navarra — Pamplona
  • Hosp Clinico Univ de Salamanca — Salamanca
Израиль · 5 центров
  • Rambam Med.Center - Hematology Institute — Haifa
  • Rambam Medical Center — Haifa
  • Carmel Medical Center — Haifa
  • Hadassah University Hospita Ein Kerem — Jerusalem
  • Tel Aviv Sourasky Medical Center — Tel Aviv
Тайвань · 4 центра
  • Chang Kung Memorial Hospital — Kaohsiung City
  • China Medical University Hospital — Taichung
  • National Cheng Kung University Hospital — Tainan
  • National Taiwan University Hospital — Taipei
Австралия · 3 центра
  • Macquarie University Hospital — Macquarie University
  • Linear Clinical Research Ltd — Nedlands
  • Scientia Clinical Research — Randwick
Франция · 3 центра
  • Hopital Claude Huriez — Lille
  • CHU Nantes — Nantes
  • Institut Gustave Roussy — Villejuif
Польша · 3 центра
  • Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz — Gdansk
  • Pratia MCM Krakow — Krakow
  • Aidport Sp z o o — Skorzewo
Великобритания · 3 центра
  • University Hospitals Of Leicester Nhs Trust — Leicester
  • St Bartholomews Hospital — London
  • University Hospitals Plymouth NHS Trust — Plymouth
Япония · 2 центра
  • National Hospital Organization Nagoya Medical Center — Nagoya
  • The Cancer Institute Hospital of JFCR — Tokyo
Бельгия · 1 центр
  • Ghent University Hospital — Ghent
Грузия · 1 центр
  • Arensia Exploratory Medicine — Tbilisi
Греция · 1 центр
  • Alexandra Hospital — Athens
Moldova · 1 центр
  • Arensia Exploratory Medicine — Chisinau
South Korea · 1 центр
  • Severance Hospital Yonsei University Health System — Seoul
Украина · 1 центр
  • Medical Center of Limited Liability Company Arensia Exploratory Medicine — Kyiv

Идентификаторы

NCT: NCT06788509 · PLATFORMPACAN1001 · PLATFORMPACAN1001 · 2024-515457-21-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗