Pragmatic Geriatric Assessment Before CAR-T or Bispecific Antibody Therapy to Predict Side Effects and Outcomes in Older Patients (GA-ACT Trial)
NCT ID: NCT07309497
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
208 participants
OBSERVATIONAL
2025-12-12
2028-02-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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geriatric assessment group
pragmatic geriatric assessment
observational study
pragmatic geriatric assessment
pragmatic geriatric assessment
Interventions
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pragmatic geriatric assessment
observational study
pragmatic geriatric assessment
pragmatic geriatric assessment
Eligibility Criteria
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Inclusion Criteria
* scheduled for CAR-T-cell or bsAB treatments
* signed informed consent
* sufficient knowledge of the German or French language
Exclusion Criteria
* refuse to consent
65 Years
ALL
No
Sponsors
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University Hospital, Zürich
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Swiss Cancer Institute
OTHER
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Wiebke Rösler, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Universitätsspital Zürich
Locations
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Inselspital Bern
Bern, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Anna Eggimann, PD Dr. med.
Role: primary
Urban Novak, Prof. Dr. med
Role: backup
Wiebke Rösler, Dr. med.
Role: primary
Stricker Helena, Dr. med.
Role: backup
Other Identifiers
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KLS-6127-08-2024-R
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BASEC-No 2025-01228
Identifier Type: -
Identifier Source: org_study_id