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

NCT07309497 | Recruiting

• 2 other identifiers: BASEC-No 2025-01228KLS-6127-08-2024-R
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma; CART Therapy; Bispecific Antibody; Geriatric Hematology

Keywords

geriatric assessment; lymphoma; multiple myeloma; bispecific antibodies; chimeric antigen receptor; outcome assessment; toxicity; health related quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• health related quality of life

  From enrollment to 3 month after end of treatment

Study Arms (1)

geriatric assessment group

Other: pragmatic geriatric assessment

Interventions

pragmatic geriatric assessment OTHER

observational study

geriatric assessment group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead
• University Hospital, Zürich: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Swiss Cancer Institute: collaborator

Study Sites (2)

Inselspital Bern

Bern, Switzerland

RECRUITING

Universitätsspital Zürich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases

Study Officials

• Wiebke Rösler, Dr. med.

  Universitätsspital Zürich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wiebke Rösler, Dr. med.

CONTACT

+4144 255 11 11; wiebke.roesler@usz.ch

Wiebke Gagesch, PD Dr. med.

CONTACT

+4144 417 11 11; michael.gagesch@stadtspital.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 30, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CH (2)