B-Cell Non-Hodgkin LymphomaPhase 2NCT06052826
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
A Phase 2 study testing Best Practice, Cognitive Intervention and Comprehensive Geriatric Assessment in people with B-Cell Non-Hodgkin Lymphoma and Multiple Myeloma, run by City of Hope Medical Center at 4 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- B-Cell Non-Hodgkin Lymphoma, Multiple Myeloma
- What is being tested?
- Best Practice, Cognitive Intervention and Comprehensive Geriatric Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Jun 2023to 5 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Ohio State University Medical Center Dept. of Internal Medicine, Division of Hematology
Columbus, Ohio, 43210
Ashley Rosko, MD, 614-293-7807, ashley.rosko@osumc.edu
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Andrew S. Artz, 626-218-2405, aartz@coh.org
Andrew S. Artz
- Recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Andrew Artz, MD, 626-218-2405, aartz@coh.org
- Recruiting
Wake Forest University, School of Medicine Dept. of Internal Medicine, Division of Hematology Oncology
Winston-Salem, North Carolina, 27157
Heidi Klepin, MD, 336-716-2255, hklepin@wakehealth.edu
About this study
Official title: 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)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate the effects of a GA-informed multi-disciplinary intervention in attenuating physical function decline among older patients receiving CAR-T therapy at day +30 post-CAR-T infusion.
SECONDARY OBJECTIVES:
- Determine success in coordinating trimodality optimization before lymphodepletion.
II. Compare rates of geriatric syndromes of frailty, cognitive impairment and malnourishment in SOC and GA-intervention cohorts at 30 days post-CAR-T infusion.
III. Evaluate rates and duration of CAR-T related neurotoxicity in SOC and GA-intervention groups.
EXPLORATORY OBJECTIVES:
- Quantify trimodality optimization intensity throughout treatment course. II. Compare longitudinal trajectory of Short Physical Performance Battery (SPPB), frailty, cognitive impairment and malnourishment between the two arms, at day +100 post-CAR-T infusion.
III. Evaluate quality of life trajectories using the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale at baseline and days +30 and +100 in both cohorts.
IV. Incidence of intensive care unit (ICU) admissions by day 100. V. Overall survival, response rate and progression-free survival through one year.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo GA before lymphodepleting chemotherapy and recommendations based on assessment results communicated to treating physicians. Patients receive physical therapy (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.
ARM II: Patients undergo GA and receive standard of care throughout study.
After completion of study treatment, patients are followed up at day 100 and then up to 1 year.
- Conditions
- B-Cell Non-Hodgkin Lymphoma, Multiple Myeloma
- Being tested
- Best Practice, Cognitive Intervention, Comprehensive Geriatric Assessment, Nutritional Intervention, Physical Therapy
- Medical subject headings
- Lymphoma, B-Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Undergo standard of care
Cognitive InterventionOther
Receive delirium prevention education
Comprehensive Geriatric AssessmentOther
Undergo geriatric assessment
Nutritional InterventionOther
Undergo nutritional optimization
Physical TherapyProcedure or surgery
Also called Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure
Undergo physical function optimization
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (PT, cognitive education, nutrition education) | Experimental | 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. Receives: Other: Cognitive Intervention; Other: Comprehensive Geriatric Assessment; Other: Nutritional Intervention; Procedure: Physical Therapy; Other: Questionnaire Administration |
| Arm II (standard of care) | Active comparator | Patients undergo GA and receive standard of care throughout study. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Short Physical Performance Battery (SPPB)
T-test will be used to compare SPPB changes score between two arms at 30 days after CAR-T infusion.
Measured: From baseline to day 30 after chimeric antigen receptor T-cell (CAR-T) infusion
Secondary outcomes (5)
Successful in coordinating initial optimization
A physical or virtual visit will be tabulated separately for functional optimization, delirium prevention and nutrition. Adherence will be deemed to have been met if >=70% or more comlete tri-modality optimization before lymphodepletion in the modified intent to treat population.
Measured: From enrollment to start of lymphodepletion
Frailty progression
Frailty progression will be defined as a score of 3 or more at T2 if T1 not frail (<3); if frail at T1 (score 3-5), any worsening of the score; a score of 5 at day 30 if baseline score already at the maximum frailty of 5.
Measured: At 30 days post CAR-T infusion
Cognitive impairment
Assessed using the Montreal Cognitive Assessment (MoCA). Cognitive impairment defined as MoCA score of < 23 or unable to complete the MoCA due to cognitive impairment. The proportion of patients with cognitive impairment at day 30, irrespective of baseline cognition, will be compared between the two arms using Chi-square test.
Measured: At 30 days post CAR-T infusion
Weight loss
Malnourishment will be measured using weight loss and dichotomized as > 5% weight loss from baseline to day +30. The proportion of patients with over 5% weight loss from T1 to T2 will be compared between the two arms using Chi-square test.
Measured: Up to 30 days post CAR-T infusion
CAR-T associated neurotoxicity
Assessed using American Society for Transplantation and Cellular Therapy consensus grading for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (ICANS). The time to neurotoxicity (days), the maximum grade (1-4) and the duration of neurotoxicity (days) will be recorded. The cumulative incidence of ICANS (percentages) will be compared between arms as well as the maximum grade (1-4), and duration of neurotoxicity (days).
Measured: Up to day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start23 Jun 2023
- Primary completion5 Sep 2027 (estimated)
- Study completion5 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andrew S Artz, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052826
- Sponsor's protocol ID
- 22422
- Other IDs
- NCI-2023-04359, 22422, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06052826
- Acronym / sponsor ID
- 22422
- Conditions
- B-Cell Non-Hodgkin Lymphoma, Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 5 Sep 2027 (estimated)
- Study completion
- 5 Sep 2027 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- Evaluate the effects of a GA-informed multi-disciplinary intervention in attenuating physical function decline among older patients receiving CAR-T therapy at day +30 post-CAR-T infusion.
SECONDARY OBJECTIVES:
- Determine success in coordinating trimodality optimization before lymphodepletion.
II. Compare rates of geriatric syndromes of frailty, cognitive impairment and malnourishment in SOC and GA-intervention cohorts at 30 days post-CAR-T infusion.
III. Evaluate rates and duration of CAR-T related neurotoxicity in SOC and GA-intervention groups.
EXPLORATORY OBJECTIVES:
- Quantify trimodality optimization intensity throughout treatment course. II. Compare longitudinal trajectory of Short Physical Performance Battery (SPPB), frailty, cognitive impairment and malnourishment between the two arms, at day +100 post-CAR-T infusion.
III. Evaluate quality of life trajectories using the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale at baseline and days +30 and +100 in both cohorts.
IV. Incidence of intensive care unit (ICU) admissions by day 100. V. Overall survival, response rate and progression-free survival through one year.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo GA before lymphodepleting chemotherapy and recommendations based on assessment results communicated to treating physicians. Patients receive physical therapy (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.
ARM II: Patients undergo GA and receive standard of care throughout study.
After completion of study treatment, patients are followed up at day 100 and then up to 1 year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (PT, cognitive education, nutrition education) | Experimental | Other: Cognitive Intervention, Other: Comprehensive Geriatric Assessment, Other: Nutritional Intervention, Procedure: Physical Therapy, Other: Questionnaire AdministrationPatients 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. |
| Arm II (standard of care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients undergo GA and receive standard of care throughout study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyUndergo standard of care | Other | Arm II (standard of care) |
| Cognitive InterventionReceive delirium prevention education | Other | Arm I (PT, cognitive education, nutrition education) |
| Comprehensive Geriatric AssessmentUndergo geriatric assessment | Other | Arm I (PT, cognitive education, nutrition education) |
| Nutritional InterventionUndergo nutritional optimization | Other | Arm I (PT, cognitive education, nutrition education) |
| Physical TherapyAlso: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy ProcedureUndergo physical function optimization | Procedure or surgery | Arm I (PT, cognitive education, nutrition education) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (PT, cognitive education, nutrition education), Arm II (standard of care) |
Primary outcome
Changes in Short Physical Performance Battery (SPPB)
Time frame: From baseline to day 30 after chimeric antigen receptor T-cell (CAR-T) infusion
T-test will be used to compare SPPB changes score between two arms at 30 days after CAR-T infusion.
5 secondary outcomes
Successful in coordinating initial optimization
Time frame: From enrollment to start of lymphodepletion
Frailty progression
Time frame: At 30 days post CAR-T infusion
Cognitive impairment
Time frame: At 30 days post CAR-T infusion
Weight loss
Time frame: Up to 30 days post CAR-T infusion
CAR-T associated neurotoxicity
Time frame: Up to day 100
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wake Forest University, School of Medicine Dept. of Internal Medicine, Division of Hematology Oncology
Winston-Salem, United States
Andrew S Artz principal investigator
City of Hope Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Best Practice, Cognitive Intervention and Comprehensive Geriatric Assessment in people with B-Cell Non-Hodgkin Lymphoma and Multiple Myeloma, run by City of Hope Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Short Physical Performance Battery (SPPB) (time frame: From baseline to day 30 after chimeric antigen receptor T-cell (CAR-T) infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.