Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), LymphomaGA-ACTNCT07309497
Pragmatic Geriatric Assessment Before CAR-T or Bispecific Antibody Therapy to Predict Side Effects and Outcomes in Older Patients (GA-ACT Trial)
An observational study of Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma and CART Therapy, run by University of Zurich at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, CART Therapy, Bispecific Antibody
- What is being tested?
- pragmatic geriatric assessment
- How many people
- 208 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 12 Dec 2025to 1 Feb 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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
Who cannot join
- inability to understand or sign informed consent
- refuse to consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Inselspital Bern
Bern
Anna Eggimann, PD Dr. med., +41 31 632 54 89, anna.eggimann@insel.ch
Urban Novak, Prof. Dr. med, +41 31 632 41 14, urban.novak@insel.ch
- Recruiting
Universitätsspital Zürich
Zurich, 8091
Wiebke Rösler, Dr. med., +4144 255 11 11, wiebke.roesler@usz.ch
Stricker Helena, Dr. med., +4144 255 11 11, helena.stricker@usz.ch
About this study
Official title: 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.
- Conditions
- Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, CART Therapy, Bispecific Antibody, Geriatric Hematology
- Being tested
- pragmatic geriatric assessment
- Keywords
- geriatric assessment, lymphoma, multiple myeloma, bispecific antibodies, chimeric antigen receptor, outcome assessment, toxicity, health related quality of life
- Medical subject headings
- Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pragmatic geriatric assessmentOther
observational study
pragmatic geriatric assessmentOther
pragmatic geriatric assessment
| Study group | Role | What they receive |
|---|---|---|
| geriatric assessment group | Not described Receives: Other: pragmatic geriatric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment toxicity
primary endpoint will be the composite rate of death or any one of ≥ grade 3 toxicity
Measured: From enrollment to 3 month after end of treatment
Secondary outcomes (1)
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
Measured: From enrollment to 3 month after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start12 Dec 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, Insel Gruppe AG, University Hospital Bern, Swiss Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Wiebke Rösler, Dr. med., Principal investigator, Universitätsspital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309497
- Sponsor's protocol ID
- BASEC-No 2025-01228
- Other IDs
- KLS-6127-08-2024-R
- Acronym
- GA-ACT
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: under discussion