NCT07309497 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zurich |
| Condition | Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 208 participants |
| Start Date | 2025-12-12 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 208 participants in total. It began in 2025-12-12 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * inability to understand or sign informed consent * refuse to consent
Contact & Investigator
Wiebke Rösler, Dr. med.
PRINCIPAL INVESTIGATOR
Universitätsspital Zürich
Frequently Asked Questions
Who can join the NCT07309497 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07309497 currently recruiting?
Yes, NCT07309497 is actively recruiting participants. Contact the research team at wiebke.roesler@usz.ch for enrollment information.
Where is the NCT07309497 trial being conducted?
This trial is being conducted at Bern, Switzerland, Zurich, Switzerland.
Who is sponsoring the NCT07309497 clinical trial?
NCT07309497 is sponsored by University of Zurich. The principal investigator is Wiebke Rösler, Dr. med. at Universitätsspital Zürich. The trial plans to enroll 208 participants.