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
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