Pragmatic Geriatric Assessment Before CAR-T or Bispecific Antibody Therapy to Predict Side Effects and Outcomes in Older Patients (GA-ACT Trial)

Официальное название

Pragmatic Geriatric Assessment (pGA) Before Bispecific Antibody and CAR-T-Cell Therapy (GA-ACT Trial) for the Prediction of Toxicity and Outcomes in Older Patients Scheduled for Chimeric Antigen Receptor T-Cell Therapy (CAR-T-Cell-Therapy) or Bispecific Antibody (bsAB) Treatment

Обзор

CAR-T cell or bispecific antibody therapies are a new treatment option for adult patients with aggressive forms of lymphoma or so-called plasma cell diseases ('multiple myeloma', 'plasma cell myeloma') that could not be cured with other, less intensive approaches. However, these are intensive therapies that can be associated with severe and potentially life-threatening side effects. Although there is no age limit for these therapies, we know little about the short- and long-term side effects of these treatments in people of advanced age. Although a small number of patients in the pivotal studies were even over 80 years old, their number was too small to be able to assess the tolerability and success specifically in people over 65. At present, the treating physicians decide whether and, if so, which patients are considered 'fit' enough for this therapy. An objective assessment of the kind we want to investigate in our study does not currently exist on a regular basis. In this study, we therefore want to use simple clinical methods to investigate the effects of these forms of therapy in different areas of everyday function that are important for people in older age (mobility, memory, self-care skills, nutrition). We want to find out whether these investigations help to predict the risk of severe and/or long-term side effects. Based on the results, a pragmatic geriatric assessment could be introduced as standard before these therapies. Older patients could thus expect an improvement in their quality of life thanks to more predictable risks and side effects. Standardized screening could lead to lower healthcare costs for treatment and aftercare for both forms of therapy.

Вмешательства

• Другое pragmatic geriatric assessment
  observational study
• Другое pragmatic geriatric assessment
  pragmatic geriatric assessment

Первичные конечные точки

• treatment toxicity [Срок оценки: From enrollment to 3 month after end of treatment]

Вторичные конечные точки (1)

• health related quality of life [Срок оценки: From enrollment to 3 month after end of treatment]

Критерии участия

Критерии включения

• male or female patients age ≥ 65 years,
• scheduled for CAR-T-cell or bsAB treatments
• signed informed consent
• sufficient knowledge of the German or French language

Критерии исключения

• inability to understand or sign informed consent
• refuse to consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 2 центра

• Inselspital Bern — Bern
• Universitätsspital Zürich — Zurich

Идентификаторы

NCT: NCT07309497 · BASEC-No 2025-01228 · KLS-6127-08-2024-R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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