Clinical trial · Interventional
Geriatric Assessment Guided Interventions to Accelerate Functional Recovery After CAR-T Therapy for Patients 60 Years and Older With B-cell Non-Hodgkin Lymphoma or Multiple Myeloma, GOCART Study
Geriatric (G) Assessment Guided Optimization (O) to Accelerate Functional Recovery After Chimeric Antigen Receptor T-Cell (CAR-T) Therapy for Patients 60 Years and Older With B-Cell Non-Hodgkin Lymphoma or Multiple Myeloma (GOCART)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This clinical trial compares the effectiveness of geriatric assessment (GA) guided interventions to accelerate functional recovery after chimeric antigen receptor T-cell (CAR-T) therapy compared to standard of care (SOC) in patients 60 years and older with B-cell non-Hodgkin lymphoma (NHL) or multiple myeloma (MM). A large number of patients diagnosed with cancer are over the age of 60, yet most cancer treatments are developed for younger patients. Therefore, older patients may be less likely to be offered stronger treatments, such as CAR-T therapy, due to possible side effects. Geriatric assessment is a multi-dimensional health assessment tool combining patient reported and objective measures covering physical function, mental processes (cognitive), and nutrition. Pre-treatment assessments may identify weaknesses in older adults and may guide interventions for physical therapy, cognitive changes and nutrition to decrease CAR-T therapy side effects and improve care in older adults with NHL or MM.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Cognitive Intervention | Other | — | UNRESOLVED |
| Comprehensive Geriatric Assessment | Other | — | UNRESOLVED |
| Nutritional Intervention | Other | — | UNRESOLVED |
| Physical Therapy | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (PT, cognitive education, nutrition education)
- description
- Patients undergo GA before lymphodepleting chemotherapy and recommendations based on assessment results communicated to treating physicians. Patients receive PT and delirium prevention education prior to lymphodepletion, at least once before CAR-T therapy, at least 2 times a week while inpatient, and at least once every other week outpatient up to day 30. Additionally, patients receive personalized nutritional guidance from a registered dietician prior to lymphodepletion, prior to CAR-T therapy and at least once a week up to day 30.
- interventionNames
- Other: Cognitive Intervention
- Other: Comprehensive Geriatric Assessment
- Other: Nutritional Intervention
- Procedure: Physical Therapy
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm II (standard of care)
- description
- Patients undergo GA and receive standard of care throughout study.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to provide informed consent * Patient's physician must agree for patient participation. A physician may elect to provide blanket agreement for participation of any eligible CAR-T patient under their care * Ability to read English, or Spanish. Other languages will be acceptable with site principal investigator (PI) agreement if surveys are available and language does not preclude completing study procedures * Age: \>= 60 years at the time of enrollment * Scheduled to receive an Food and Drug Administration (FDA)-approved CAR-T for treatment of multiple myeloma or B-cell non- Hodgkin lymphoma * Willing and able to complete study requirements * Patients expect to be able to participate at least once before lymphodepletion with trimodality optimization visits Exclusion Criteria: * Prior CAR-T therapy * Any condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
References
Publications (0)
Data not yet available