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Geriatrisk vurdering Guidede interventioner for at fremskynde funktionel restitution efter CAR-T-terapi for patienter 60 år og ældre med B-celle non-Hodgkin lymfom eller myelomatose, GOCART-undersøgelse

20. oktober 2026 opdateret af: City of Hope Medical Center

Geriatrisk (G) vurdering Guidet optimering (O) for at fremskynde funktionel restitution efter kimærisk antigenreceptor T-celle (CAR-T) terapi til patienter 60 år og ældre med B-cellet non-Hodgkin lymfom eller myelomatose (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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVE:

I. 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:

I. 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:

I. 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

164

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Duarte, California, Forenede Stater, 91010
        • Rekruttering
        • City of Hope Medical Center
        • Kontakt:
          • Andrew S. Artz
          • Telefonnummer: 626-218-2405
          • E-mail: aartz@coh.org
        • Ledende efterforsker:
          • Andrew S. Artz
      • Irvine, California, Forenede Stater, 92618
        • Rekruttering
        • City of Hope at Irvine Lennar
        • Kontakt:
          • Andrew Artz, MD
          • Telefonnummer: 626-218-2405
          • E-mail: aartz@coh.org
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Rekruttering
        • Wake Forest University, School of Medicine Dept. of Internal Medicine, Division of Hematology Oncology
        • Kontakt:
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Rekruttering
        • Ohio State University Medical Center Dept. of Internal Medicine, Division of Hematology
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm I (PT, cognitive education, nutrition education)

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.
Andet: Questionnaire Administration

Ancillary studies

Andet: Cognitive Intervention

Receive delirium prevention education

Andet: Comprehensive Geriatric Assessment

Undergo geriatric assessment

Andet: Nutritional Intervention

Undergo nutritional optimization

Procedure: Physical Therapy

Undergo physical function optimization

Andre navne:
  • PT
  • Fysiatrisk procedure
  • Fysisk medicinsk procedure
  • Fysioterapi
  • Fysioterapi procedure
Aktiv komparator: Arm II (standard of care)

Patients undergo GA and receive standard of care throughout study.
Andet: Questionnaire Administration

Ancillary studies

Andet: Best Practice

Undergo standard of care

Andre navne:
  • plejestandard
  • standard terapi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Short Physical Performance Battery (SPPB)
Tidsramme: 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.
From baseline to day 30 after chimeric antigen receptor T-cell (CAR-T) infusion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Successful in coordinating initial optimization
Tidsramme: From enrollment to start of lymphodepletion

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.
From enrollment to start of lymphodepletion
Frailty progression
Tidsramme: At 30 days post CAR-T infusion

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.
At 30 days post CAR-T infusion
Cognitive impairment
Tidsramme: At 30 days post CAR-T infusion

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.
At 30 days post CAR-T infusion
Weight loss
Tidsramme: Up to 30 days post CAR-T infusion

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.
Up to 30 days post CAR-T infusion
CAR-T associated neurotoxicity
Tidsramme: Up to day 100

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).
Up to day 100

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

City of Hope Medical Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Andrew S Artz, City of Hope Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. juni 2023

Primær færdiggørelse (Anslået)

5. september 2027

Studieafslutning (Anslået)

5. september 2027

Datoer for studieregistrering

Først indsendt

11. september 2023

Først indsendt, der opfyldte QC-kriterier

19. september 2023

Først opslået (Faktiske)

25. september 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 22422
  • P30CA033572 (U.S. NIH-bevilling/kontrakt)
  • 22422 (Anden identifikator: City of Hope Medical Center)
  • NCI-2023-04359 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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