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NCT07309497Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 30 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
208 (estimated)
First submitted
15 Dec 2025
Start date
12 Dec 2025
Primary completion date
1 Dec 2027
Lead sponsor
University of Zurich
NCT number
NCT07309497

What you commit to

  • Study type: Observational
  • Planned participants: 208
  • From 12 Dec 2025 to the primary completion date, 1 Dec 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Inselspital Bern
Coordinator of this site? Confirm its status
BernSwitzerlandRecruiting
Universitätsspital Zürich
Coordinator of this site? Confirm its status
ZurichSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.