Меню
Идёт набор NCT06957314

A Study of Hospital-at-Home for People Receiving Tarlatamab

Без фазы С лечением Small-cell Lung Cancer Small Cell Lung Carcinoma

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: Hospital-at-Home/HAH.
Кому может быть актуально
Состояния в реестре: Small-cell Lung Cancer, Small Cell Lung Carcinoma. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

MATCHES-Novel: MAking Telehealth Delivery of Cancer Care at Home Effective and Safe for Novel Therapies: A Hospital-at-Home Model for Tarlatamab Delivery

Обзор

The purpose of this study is to find out whether a Hospital-at-Home (HaH) program is a more efficient way to monitor people's health after receiving tarlatamab than monitoring in the hospital (inpatient).

Вмешательства

  • Другое Hospital-at-Home/HAH
    After discharge, a SeniorCare community paramedic will provide a home visit to the participant's home or residence

Первичные конечные точки

  • Number of inpatient hospital days [Срок оценки: 14 days]

Критерии участия

Критерии включения

Patient

  • Diagnosis of extensive stage small cell lung carcinoma (ES-SCLC)
  • Treatment plan of commercially available tarlatamab monotherapy as standard of care
  • Patients must be 18 years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status <2
  • Patients must have adequate organ and bone marrow function, defined by the following laboratory results obtained within 28 days prior to the first study treatment:
  • ANC ≥ 1000 cells/μL (without granulocyte colony stimulating factor support within 4 weeks prior to Cycle 1, Day 1)
  • Platelet count ≥50,000/μL (without transfusion within 4 weeks prior to Cycle 1, Day 1)
  • Hemoglobin ≥8.0 g/dL (without transfusion within 4 weeks prior to Cycle 1, Day 1)
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 X upper limit of normal (ULN). Serum bilirubin ≤ 1.5 x ULN. Patients with known Gilbert disease who have serum bilirubin level ≤ 2 x ULN may be enrolled.
  • Estimated Glomerular Filtration Rate (eGFR) ≥ 30mL/min using the CKD-EPI formula.
  • The patient is willing to give and sign informed consent
  • Appropriate homebound setting as defined by one of the following:
  • Lodging at MSK Residence or hotel
  • 5 New York City boroughs, lower Westchester County (northern boundary Cross County Parkway) and Nassau County (eastern boundary Wantagh State Parkway). This is based on the community paramedic (SeniorCare) 60-minute response time catchment area. If there is any uncertainty about patient residence eligibility, the Principal Investigator will decide after discussion with SeniorCare.
  • Patients must be accompanied by a caregiver for the period of time the patient is enrolled in the HaH intervention. For cases where there is uncertainty, the Principal Investigator will make the final determination.

Caregiver

  • Primary caregiver as identified by patient enrolled on study

Physician

  • Treating physician for patient(s) enrolled on study; managing treatment plan of commercially available tarlatamab as standard of care

Критерии исключения

Patient

  • Patients with a documented active infection prior to starting tarlatamab. This includes grade 3 or higher viral, bacterial, or fungal infection.
  • Patients with baseline dementia or cognitive barriers
  • Uncontrolled arrhythmias

Caregiver

  • Caregiver deemed inappropriate by treating physician

Physician

  • No exclusion criteria

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 7 центров
  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale

Идентификаторы

NCT: NCT06957314 · 25-077

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗