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CAR T-cell Therapy

Geriatric Assessments and Interventions for Lymphoma and Multiple Myeloma

Phase 2

Recruiting

Led By Andrew S Artz

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled to receive an Food and Drug Administration (FDA)-approved CAR-T for treatment of multiple myeloma or B-cell non- Hodgkin lymphoma

Age: >= 60 years at the time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 100

Awards & highlights

Study Summary

This trial studies if pre-treatment assessment and interventions can help older cancer patients get better treatments and improve care.

Who is the study for?

This trial is for people aged 60 or older with B-cell non-Hodgkin lymphoma or multiple myeloma who are about to receive FDA-approved CAR-T therapy. They must understand English or Spanish, be able to consent, and their doctor must agree they can join. Those who've had prior CAR-T therapy or have conditions that make the study unsafe cannot participate.Check my eligibility

What is being tested?

The GOCART Study tests if special assessments and interventions based on geriatric health (covering physical function, cognition, nutrition) can help older adults recover faster after CAR-T therapy compared to standard care. It aims to tailor treatments better suited for patients' age-related needs.See study design

What are the potential side effects?

While not specific about side effects of interventions like physical therapy and nutritional support, these are generally safe. The main treatment being supported by these interventions is CAR-T therapy which can cause immune reactions, fatigue, infection risk among other side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for CAR-T therapy for my multiple myeloma or B-cell lymphoma.

Select...

I am 60 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to start of lymphodepletion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to start of lymphodepletion

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to start of lymphodepletion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Short Physical Performance Battery (SPPB)

Secondary outcome measures

CAR-T associated neurotoxicity

Cognitive impairment

Frailty progression

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (PT, cognitive education, nutrition education)Experimental Treatment5 Interventions

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.

Group II: Arm II (standard of care)Active Control2 Interventions

Patients undergo GA and receive standard of care throughout study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Therapy

2020

Completed Phase 4

~1460

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,277 Total Patients Enrolled

581 Trials studying Multiple Myeloma

189,037 Patients Enrolled for Multiple Myeloma

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,496 Total Patients Enrolled

37 Trials studying Multiple Myeloma

3,295 Patients Enrolled for Multiple Myeloma

Andrew S ArtzPrincipal InvestigatorCity of Hope Medical Center

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What sort of risks have been associated with Arm I (PT, cognitive education, nutrition education)?

"Considering the limited evidence of efficacy and existing data on safety, our Power team has assigned Arm I (PT, cognitive education, nutrition education) a score of 2."

Answered by AI

Is enrollment still possible for this particular research trial?

"Absolutely. Clinicaltrials.gov data reveals that this research study, which was first listed on June 23rd 2023 is still looking for participants to take part in the experiment. 164 individuals need to be enlisted from one site only."

Answered by AI

How many individuals have been recruited for this research project thus far?

"Affirmative. According to clinicaltrials.gov, this trial is actively recruiting participants; it was initially posted on June 23rd 2023 and most recently updated on September 19th of the same year. This study requires 164 patients from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06052826.