Actively Recruiting

Age: 65Years +
All Genders
ID07309497

Pragmatic Geriatric Assessment Before Bispecific Antibody and CAR-T-Cell Therapy to Predict Toxicity and Outcomes in Older Patients

Led by University of Zurich · Updated on 2025-12-30

208

Participants Needed

2

Research Sites

8 weeks

Total Duration

On this page

Sponsors

U

University of Zurich

Lead Sponsor

U

University Hospital, Zürich

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of CAR-T cell and bispecific antibody therapies in older adults aged 65 and above who have aggressive types of lymphoma or plasma cell diseases like multiple myeloma. These treatments are new and intense, with potential serious side effects, but little is known about how older patients tolerate them or what the long-term impacts are. The study aims to use simple clinical methods to assess everyday functions important to older adults, such as mobility and memory, to better predict treatment risks and side effects. The study involves a pragmatic geriatric assessment before patients undergo CAR-T or bispecific antibody therapies. This assessment focuses on areas like mobility, self-care, nutrition, and cognitive function to evaluate patients' fitness for these treatments. The goal is to see if these assessments can predict severe or lasting side effects and improve treatment planning for older patients. This observational study does not involve assigning specific treatments but monitors patients receiving these therapies as part of their care. During the study, participants will be evaluated from enrollment through three months after treatment ends for treatment toxicity and health-related quality of life. Researchers will use the assessments to monitor side effects and outcomes over time. The study also aims to develop a standardized screening process that could become routine before such therapies, potentially improving quality of life and reducing healthcare costs for older patients receiving these treatments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients age 65 years or older
  • Scheduled for CAR-T-cell or bispecific antibody treatments
  • Signed informed consent
  • Sufficient knowledge of the German or French language
Not Eligible

You will not qualify if you...

  • Inability to understand or sign informed consent
  • Refusal to consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to enrollment

Participants undergo a pragmatic geriatric assessment before receiving CAR-T or bispecific antibody therapy.

1 visit (in-person)

Long-term Monitoring

Duration - From enrollment to 3 months after end of treatment

Participants are observed for treatment toxicity and health-related quality of life after therapy.

Visits as per treatment follow-up schedule

Trial Site Locations

Total: 2 locations

1

Inselspital Bern

Bern, Switzerland

Actively Recruiting

2

Universitätsspital Zürich

Zurich, Switzerland, 8091

Actively Recruiting

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Research Team

W

Wiebke Rösler, Dr. med.

W

Wiebke Gagesch, PD Dr. med.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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