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Geriatrisk vurdering Veiledede intervensjoner for å akselerere funksjonell utvinning etter CAR-T-terapi for pasienter 60 år og eldre med B-celle non-Hodgkin lymfom eller multippelt myelom, GOCART-studie

20. oktober 2026 oppdatert av: City of Hope Medical Center

Geriatrisk (G) vurdering Veiledet optimalisering (O) for å akselerere funksjonell utvinning etter kimær antigenreseptor T-celle (CAR-T) terapi for pasienter 60 år og eldre med B-celle non-Hodgkin lymfom eller multippelt myelom (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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

164

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Duarte, California, Forente stater, 91010
        • Rekruttering
        • City of Hope Medical Center
        • Ta kontakt med:
          • Andrew S. Artz
          • Telefonnummer: 626-218-2405
          • E-post: aartz@coh.org
        • Hovedetterforsker:
          • Andrew S. Artz
      • Irvine, California, Forente stater, 92618
        • Rekruttering
        • City of Hope at Irvine Lennar
        • Ta kontakt med:
          • Andrew Artz, MD
          • Telefonnummer: 626-218-2405
          • E-post: aartz@coh.org
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater, 27157
        • Rekruttering
        • Wake Forest University, School of Medicine Dept. of Internal Medicine, Division of Hematology Oncology
        • Ta kontakt med:
    • Ohio
      • Columbus, Ohio, Forente stater, 43210
        • Rekruttering
        • Ohio State University Medical Center Dept. of Internal Medicine, Division of Hematology
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Questionnaire Administration

Ancillary studies

Annen: Cognitive Intervention

Receive delirium prevention education

Annen: Comprehensive Geriatric Assessment

Undergo geriatric assessment

Annen: Nutritional Intervention

Undergo nutritional optimization

Fremgangsmåte: Physical Therapy

Undergo physical function optimization

Andre navn:
  • PT
  • Fysiatrisk prosedyre
  • Fysisk medisin prosedyre
  • Fysioterapi
  • Fysioterapiprosedyre
  • Fysioterapi prosedyre
Aktiv komparator: Arm II (standard of care)

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

Ancillary studies

Annen: Best Practice

Undergo standard of care

Andre navn:
  • velferdstandard
  • standard terapi

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

City of Hope Medical Center

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Andrew S Artz, City of Hope Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. juni 2023

Primær fullføring (Antatt)

5. september 2027

Studiet fullført (Antatt)

5. september 2027

Datoer for studieregistrering

Først innsendt

11. september 2023

Først innsendt som oppfylte QC-kriteriene

19. september 2023

Først lagt ut (Faktiske)

25. september 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 22422
  • P30CA033572 (U.S. NIH-stipend/kontrakt)
  • 22422 (Annen identifikator: City of Hope Medical Center)
  • NCI-2023-04359 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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