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

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

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.

Study Overview

• Status: Recruiting
• Conditions: CART Therapy; Bispecific Antibody; Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma; Geriatric Hematology
• Intervention / Treatment: Other: pragmatic geriatric assessment; Other: pragmatic geriatric assessment

• Study Type: Observational
• Enrollment (Estimated): 208

Contacts and Locations

• Study Contact: Name: Wiebke Rösler, Dr. med.; Phone Number: +4144 255 11 11; Email: wiebke.roesler@usz.ch
• Study Contact Backup: Name: Wiebke Gagesch, PD Dr. med.; Phone Number: +4144 417 11 11; Email: michael.gagesch@stadtspital.ch

Study Locations

• Switzerland
  • Bern, Switzerland
    • Recruiting
    • Inselspital Bern
    • Contact: Anna Eggimann, PD Dr. med.; Phone Number: +41 31 632 54 89; Email: anna.eggimann@insel.ch
    • Contact: Urban Novak, Prof. Dr. med; Phone Number: +41 31 632 41 14; Email: urban.novak@insel.ch
    • Principal Investigator: Anna Eggimann, PD Dr. med.
    • Sub-Investigator: Urban Novak, Prof. Dr.med.
    • Sub-Investigator: Jörg Beyer, Prof. Dr. med.
  • Zurich, Switzerland, 8091
    • Recruiting
    • UniversitätsSpital Zürich
    • Contact: Wiebke Rösler, Dr. med.; Phone Number: +4144 255 11 11; Email: wiebke.roesler@usz.ch
    • Contact: Stricker Helena, Dr. med.; Phone Number: +4144 255 11 11; Email: helena.stricker@usz.ch
    • Principal Investigator: Wiebke Rösler, Dr. med.
    • Sub-Investigator: Helena Stricker, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients age ≥ 65 years and older, treated at the University Hospitals in Bern and Zurich and undergoing CAR-T-cell or bsAB therapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
geriatric assessment group	Other: pragmatic geriatric assessment; observational study; Other: pragmatic geriatric assessment; pragmatic geriatric assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment toxicity	primary endpoint will be the composite rate of death or any one of ≥ grade 3 toxicity	From enrollment to 3 month after end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
health related quality of life	Secondary endpoints will be the rate of transfer to intensive care units, the length of hospital stay, the discharge home versus to rehab or nursing-care facilities as well as changes in physical function, cognitive function, nutritional status, ability of self-care and the quality-of-life at discharge and three months after start of therapy. In addition premature CAR-T or bsAB discontinuation, the frequency of treatment-specific toxicities such as the cytokine-release syndrome (CRS) and the immune effector cell-associated neurotoxicity syndrome (ICANS) will be captured	From enrollment to 3 month after end of treatment

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: University Hospital, Zürich; Insel Gruppe AG, University Hospital Bern; Swiss Cancer Institute
• Investigators: Principal Investigator: Wiebke Rösler, Dr. med., UniversitätsSpital Zürich

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: lymphoma; health related quality of life; toxicity; multiple myeloma; chimeric antigen receptor; outcome assessment; geriatric assessment; bispecific antibodies
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Lymphoma; Multiple Myeloma
• Other Study ID Numbers: BASEC-No 2025-01228; KLS-6127-08-2024-R (Other Grant/Funding Number: Krebsliga Schweiz)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: under discussion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No