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Effekt og sikkerhed af Tisagenlecleucel hos voksne patienter med refraktært eller recidiverende follikulært lymfom (ELARA)

19. maj 2026 opdateret af: Novartis Pharmaceuticals

Et fase II, enkeltarm, multicenter åbent-label-forsøg for at bestemme effektiviteten og sikkerheden af ​​Tisagenlecleucel (CTL019) hos voksne patienter med refraktært eller recidiverende follikulært lymfom

Dette er et multicenter, fase II-studie for at bestemme effektiviteten og sikkerheden af ​​tisagenlecleucel hos voksne patienter med recidiverende eller refraktær FL.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Denne enkeltarmede, åbne undersøgelse havde følgende sekventielle faser: Screening, forbehandling, behandling og opfølgning. I forbehandlingsfasen kunne patienten gennemgå brobehandling (valgfrit) og lymfodepletende (LD) kemoterapi. Behandlings- og opfølgningsfasen omfattede tisagenlecleucel-infusion og sikkerheds- og effektopfølgning i mindst 24 måneder. For alle patienter, der fik tisagenlecleucel-infusion, skulle der udføres yderligere overlevelsesopfølgning for at bestemme overlevelsesstatus hver 3. måned.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

98

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Australien
      • Herston, Australien, QLD 4006
        • Novartis Investigative Site
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
        • Novartis Investigative Site
    • Victoria
      • Melbourne, Victoria, Australien, 3000
        • Novartis Investigative Site
  • Belgien
      • Ghent, Belgien, 9000
        • Novartis Investigative Site
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, SE5 9RS
        • Novartis Investigative Site
    • West Midlands
      • Birmingham, West Midlands, Det Forenede Kongerige, B15 2TH
        • Novartis Investigative Site
  • Forenede Stater
    • California
      • Duarte, California, Forenede Stater, 91010 3000
        • City of Hope National Medical Center
      • San Francisco, California, Forenede Stater, 94143
        • UCSF Medical Center
    • Florida
      • Tampa, Florida, Forenede Stater, 33612
        • H Lee Moffitt Cancer Center and Research Institute
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • Uni of Chi Medi Ctr Hema and Onco
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Univ of Kansas Hosp and Med Ctr
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109 5271
        • Michigan Med University of Michigan
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania Clinical
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • MD Anderson Cancer Center
  • Frankrig
      • Paris, Frankrig, 75475
        • Novartis Investigative Site
      • Pierre-Bénite, Frankrig, 69495
        • Novartis Investigative Site
  • Holland
    • North Holland
      • Amsterdam, North Holland, Holland, 1081 HV
        • Novartis Investigative Site
  • Italien
    • BO
      • Bologna, BO, Italien, 40138
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italien, 20132
        • Novartis Investigative Site
  • Japan
      • Fukuoka, Japan, 8128582
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Novartis Investigative Site
    • Miyagi
      • Sendai, Miyagi, Japan, 9808574
        • Novartis Investigative Site
  • Norge
      • Oslo, Norge, 0310
        • Novartis Investigative Site
  • Spanien
      • Madrid, Spanien, 28041
        • Novartis Investigative Site
      • Seville, Spanien, 41013
        • Novartis Investigative Site
  • Tyskland
      • Ulm, Tyskland, 89081
        • Novartis Investigative Site
    • Bavaria
      • Munich, Bavaria, Tyskland, 81377
        • Novartis Investigative Site
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Tyskland, 50937
        • Novartis Investigative Site
  • Østrig
      • Linz, Østrig, 4020
        • Novartis Investigative Site

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Refraktært eller recidiverende follikulært lymfom (grad 1, 2, 3A)
  • Radiografisk målbar sygdom ved screening

Ekskluderingskriterier:

  • Bevis på histologisk transformation
  • Follikulært lymfom grad 3B
  • Tidligere anti-CD19-behandling
  • Tidligere genterapi
  • Forudgående adoptiv T-celleterapi
  • Tidligere allogen hæmatopoietisk stamcelletransplantation
  • Aktiv CNS involvering ved malignitet

Andre protokoldefinerede inklusions-/eksklusionskriterier kan være gældende.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CTL019
Alle patienter, der fik tisagenlecleucel-infusion.
Biologisk: tisagenlecleucel
Tisagenlecleucel er en enkelt infusion.
Andre navne:
  • CTL019

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fuldstændig responsrate (CRR) pr. uafhængig vurderingskomité (IRC) vurdering
Tidsramme: 1 år
Fuldstændig responsrate blev defineret som procentdelen af ​​deltagere med det bedste overordnede respons (BOR) af komplet respons (CR) registreret fra tisagenlecleucel-infusion indtil progressiv sygdom eller start af ny anticancerterapi, alt efter hvad der kom først. CRR blev bestemt af en uafhængig revisionskomité (IRC) og var baseret på Lugano 2014 klassifikationsresponskriterier. Den radiologiske respons opnås først fra CT- og PET-studier i henhold til Lugano 2014-kriterierne. CT-respons er baseret på anatomiske målinger af indeks/ikke-indeks/nye læsioner og miltlængde. De mulige responsresultater er komplet respons (CR), partiel respons (PR), stabil sygdom (SD) eller progressiv sygdom (PD). PET-respons baseret på en 5-punkts skala (5PS) eller Deauville-score. De mulige resultater for PET-respons er komplet metabolisk respons (CMR), partiel metabolisk respons (PMR), ingen metabolisk respons (NMR) eller progressiv metabolisk sygdom (PMD).
1 år

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Response Rate (ORR) pr. IRC-vurdering
Tidsramme: 1 år
Samlet responsrate er defineret som procentdelen af ​​deltagere med det bedste overordnede sygdomsrespons af komplet respons (CR) eller delvis respons (PR). Responsen blev evalueret i henhold til Lugano 2014 klassificeringsresponskriterier. Den radiologiske respons opnås først fra CT- og PET-studier i henhold til Lugano 2014-kriterierne. CT-respons er baseret på anatomiske målinger af indeks/ikke-indeks/nye læsioner og miltlængde. De mulige responsresultater er komplet respons (CR), partiel respons (PR), stabil sygdom (SD) eller progressiv sygdom (PD). PET-respons baseret på en 5-punkts skala (5PS) eller Deauville-score. De mulige resultater for PET-respons er komplet metabolisk respons (CMR), partiel metabolisk respons (PMR), ingen metabolisk respons (NMR) eller progressiv metabolisk sygdom (PMD).
1 år
Duration of Response (DOR) Per IRC Assessment
Tidsramme: approx. 60 months
Duration of response (DOR) applied only to participants whose best overall disease response was CR or PR. It is defined as the time from the date of first documented disease response (CR or PR) to the date of first documented progression or death due to follicular lymphoma (FL). DOR was estimated using the Kaplan-Meier method.
approx. 60 months
Duration of Response (DOR) for Complete Response (CR) Only Per IRC Assessment
Tidsramme: approx. 60 months
Duration of response (DOR) applied only to participants whose best overall disease response was complete response (CR) only. It is defined as the time from the date of first documented disease response (CR only) to the date of first documented progression or death due to follicular lymphoma (FL). DOR was estimated using the Kaplan-Meier method.
approx. 60 months
Progression Free Survival (PFS) Per IRC Assessment
Tidsramme: up to 61.7 months
Progression free survival is the time from tisagenlecleucel infusion to first documented disease progression or death due to any cause. PFS was estimated using the Kaplan-Meier method.
up to 61.7 months
Overall Survival (OS)
Tidsramme: up to 65.8 months
Overall Survival is the time from tisagenlecleucel infusion to death due to any cause. OS was estimated using the Kaplan-Meier method.
up to 65.8 months
Tisagenlecleucel Transgene Concentration Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) Method, by Clinical Response Per IRC Assessment
Tidsramme: Month 60 (peripheral blood), Month 6 (bone marrow)
This is the summary of cellular kinetic concentrations for tisagenlecleucel (CTL019) transgene levels in peripheral blood and bone marrow following infusion.
Month 60 (peripheral blood), Month 6 (bone marrow)
Cmax; Cellular Kinetic Parameter of Tisagenlecleucel Transgene Levels by qPCR, Based on Clinical Response IRC Assessment
Tidsramme: up to 60 months after infusion
Cmax is the maximum (peak) observed in peripheral blood after single dose administration. Actual sampling times were taken into consideration for the calculation of cellular kinetic parameters parameters.
up to 60 months after infusion
Tmax; Cellular Kinetic Parameter of Tisagenlecleucel Transgene Levels by qPCR, Based on Clinical Response by IRC Assessment
Tidsramme: up to 60 months after infusion
Tmax is the time to reach maximum (peak) peripheral blood after single dose administration (days). Actual sampling times were taken into consideration for the calculation of cellular kinetic parameters.
up to 60 months after infusion
AUC0-28d and AUC0-84d; Cellular Kinetic Parameter of Tisagenlecleucel Transgene Levels by qPCR, Based on Clinical Response by IRC Assessment
Tidsramme: 0 to 28 days after infusion, 0 to 84 days after infusion
AUC0-28 is the area under curve (AUC) from time zero to day 28 in peripheral blood. AUC0-84d is the AUC from time zero to day 84 in peripheral blood. Actual sampling times were taken into consideration for the calculation of cellular kinetic parameters.
0 to 28 days after infusion, 0 to 84 days after infusion
AUC0-28d and AUC0-84d; Cellular Kinetic Parameter for Tisagenlecleucel by Flow Cytometry, Based on Clinical Response by IRC Assessment
Tidsramme: AUC0-28d: from time of infusion to 28 days post-dose; AUC0-84d: from time of infusion to 84 days post-infusion
Exposure is summarized as area under the curve (AUC) from time 0 to 28 days (AUC0-28d) and from time to 84 days (AUC0-84d). The cellular kinetic parameters were estimated from the percentages of CD3+/CTL019+ cells obtained from flow cytometry. Flow cytometry measures the surface expression of chimeric antigen receptors (CARs) on T cells.
AUC0-28d: from time of infusion to 28 days post-dose; AUC0-84d: from time of infusion to 84 days post-infusion
Cmax; Cellular Kinetic Parameter for Tisagenlecleucel by Flow Cytometry, Based on Clinical Response by IRC Assessment
Tidsramme: From pre-dose until 60 months after infusion
Cmax is the maximum (peak) observed in peripheral blood after single dose administration. Actual sampling times were taken into consideration for the calculation of cellular kinetic parameters parameters.
From pre-dose until 60 months after infusion
Summary of Exposure of CD3+ Tisagenlecleucel Cells in Peripheral Blood for Tmax
Tidsramme: From pre-dose until 60 months after infusion
In vivo cellular kinetics of CD3+/CTL019+ levels tisagenlecleucel cells detected by flow cytometry base on best overall response (BOR). The cellular kinetic parameters were estimated from the percentages of CD3+/CTL019+ cells obtained from flow cytometry. Flow cytometry measures the surface expression of chimeric antigen receptors (CARs) on T cells.
From pre-dose until 60 months after infusion
Humoral Immunogenicity: Number of Participants With Anti-mCAR19 Antibodies, Per IRC Assessment
Tidsramme: at any time post-baseline, up to 24 months post-infusion
Antibody titers specific to the tisagenlecleucel molecule prior to and following infusion. Percentage of participants who tested positive for anti-mCAR19 antibodies at any time post-baseline. A participant was only defined as positive for tisagenlecleucel treatment-induced or -boosted anti-mCAR19 antibodies when the anti-mCAR19 antibody median fluorescence intensity (MFI) at any time post-infusion was at least 2.28-fold higher than pre-infusion levels for patients whose baseline status was positive (boosted) or if the baseline status was negative, but any post-baseline interpretation was positive (induced).
at any time post-baseline, up to 24 months post-infusion
Cellular Immunogenicity: Percentage of Interferon Gamma (IFNg+) Cells by Flow Cytometry Per IRC Assessment
Tidsramme: pre-infusion (pre-Lymph depletion evaluation), 24 months post-infusion

Activation of T-cells in peripheral blood mononuclear cells collected from participants in response to mCAR19-derived peptides was used to assess the cellular immunogenicity against tisagenlecleucel. T-cell activation was measured by the percentage of interferon gamma (IFNg+) cells by flow cytometry. Cellular responses to mCART peptides were measured pre-infusion (enrollment) and post-tisagenlecleucel infusion.

Pool 1 and Pool 2 are a pool of 60 peptides (peptides 1-60) and 59 peptides (peptides 61-119) , respectively, corresponding to the CTL019 transgene product. Together, they comprised 119 peptides spanning the CTL019 transgene product and were used to stimulate PBMCs to detect antigen-specific T cell responses via intracellular cytokine staining.
pre-infusion (pre-Lymph depletion evaluation), 24 months post-infusion
Summary Scores of Patient-reported Outcome (PRO) Measured by SF-36v2 Quality of Life Questionnaire by Visit
Tidsramme: Baseline (BL) Month (M) 3, M3, M6, M9, M12, M18, M24
Effect of tisagenlecleucel therapy on patient reported outcomes were reported using the Short Form Health Survey (SF-36) v2 form. The SF-36 v2 is a widely used and extensively studied instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) were computed by summing the item responses on the questions for each domain in accordance with the respective scoring method provided by the developers. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. A high score defines a more favorable health state.
Baseline (BL) Month (M) 3, M3, M6, M9, M12, M18, M24
Summary Scores of PRO Measured by SF-36v2 Quality of Life Questionnaire Reported by Change From Baseline
Tidsramme: Change from baseline (CFB) M3, CFB M6, CFB M9, CFB M12, CFB M18, CFB M24
Effect of tisagenlecleucel therapy on patient reported outcomes were reported using the Short Form Health Survey (SF-36) v2 form. The SF-36 v2 is a widely used and extensively studied instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) were computed by summing the item responses on the questions for each domain in accordance with the respective scoring method provided by the developers. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. A high score defines a more favorable health state.
Change from baseline (CFB) M3, CFB M6, CFB M9, CFB M12, CFB M18, CFB M24
Health Status Measured by EQ-5D-3L Questionnaire
Tidsramme: Baseline (BL), Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 36
Effect of tisagenlecleucel therapy on patient-reported outcomes was assessed using the EuroQol 5-Dimension, 3-Level instrument (EQ-5D-3L). The EQ-5D-3L is a widely used, self-administered questionnaire designed to evaluate health status in adults. It consists of two sections. The first includes one item for each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients rate each dimension as "no problems" (level 1), "some problems" (level 2), or "extreme problems" (level 3). This record summarizes, for each of the five dimensions, the number of patients falling into each response level.
Baseline (BL), Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 36
Summary Scores of PRO Measured by EQ-VAS Quality of Life Questionnaire by Visit
Tidsramme: Baseline (BL) Month (M) 3, M6, M9, M12, M18, M24, M36
Effect of tisagenlecleucel therapy on patient reported outcomes were reported using the EQ-VAS (EuroQol Visual Analogue Scale). The EQ-VAS is a 20 cm vertical, 0-100 numerical scale used alongside the EQ-5D questionnaire to measure a patient's self-rated health. It anchors "best imaginable health" (100) at the top and "worst imaginable health" (0) at the bottom, providing a quick, subjective, quantitative, and global assessment of health status on the day of survey. The second section of the questionnaire measures self-rated (global) health status utilizing a vertically oriented visual analogue scale where 100 represents the "best possible health state" and 0 represents the "worst possible health state."
Baseline (BL) Month (M) 3, M6, M9, M12, M18, M24, M36
Summary Scores of PRO Measured by EQ-VAS Quality of Life Questionnaire Reported by Change From Baseline
Tidsramme: Baseline (BL), M3 change from baseline (CFB), M6 CFB, M9 CFB, M12 CFB, M18 CFB, M24 CFB, M36 CFB
Effect of tisagenlecleucel therapy on patient reported outcomes were reported using the EQ-VAS (EuroQol Visual Analogue Scale). The EQ-VAS is a 20 cm vertical, 0-100 numerical scale used alongside the EQ-5D questionnaire to measure a patient's self-rated health. It anchors "best imaginable health" (100) at the top and "worst imaginable health" (0) at the bottom, providing a quick, subjective, quantitative, and global assessment of health status on the day of survey
Baseline (BL), M3 change from baseline (CFB), M6 CFB, M9 CFB, M12 CFB, M18 CFB, M24 CFB, M36 CFB
Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire
Tidsramme: Baseline (BL) Month (M) 3, M6, M9, M12, M18, M24, M36
The effect of tisagenlecleucel therapy on patient-reported outcomes was assessed using the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire, which measures quality of life in participants with lymphoma. FACT-Lym is composed of the FACT-G (27 items across Physical, Social/Family, Emotional, and Functional Well-Being, plus Additional Concerns) and a 15-item lymphoma-specific subscale. All items use a five-point self-administered response scale (0-4), with higher scores indicating better quality of life. The possible score ranges are as follows: - Physical Well-Being (PWB): 0-28 - Social/Family Well-Being (SWB): 0-28 - Emotional Well-Being (EWB): 0-24 - Functional Well-Being (FWB): 0-28 - Lym Subscale (15 items): 0-60 - Lymphoma Trial Outcome Index (TOI: PWB + FWB + Lym): 0-116 - FACT-G Total (PWB + SWB + EWB + FWB): 0-108 - FACT-Lym Total (FACT-G + Lym): 0-168 In all cases, higher scores indicate better outcomes within the corresponding domain.
Baseline (BL) Month (M) 3, M6, M9, M12, M18, M24, M36
Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire Reported by Change From Baseline
Tidsramme: Baseline (BL), M3 change from baseline (CFB), M6 CFB, M9 CFB, M12 CFB, M18 CFB, M24 CFB, M36 CFB
The effect of tisagenlecleucel therapy on patient-reported outcomes was assessed using the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire, which measures quality of life in participants with lymphoma. FACT-Lym is composed of the FACT-G (27 items across Physical, Social/Family, Emotional, and Functional Well-Being, plus Additional Concerns) and a 15-item lymphoma-specific subscale. All items use a five-point self-administered response scale (0-4), with higher scores indicating better quality of life. The possible score ranges are as follows: - Physical Well-Being (PWB): 0-28 - Social/Family Well-Being (SWB): 0-28 - Emotional Well-Being (EWB): 0-24 - Functional Well-Being (FWB): 0-28 - Lym Subscale (15 items): 0-60 - Lymphoma Trial Outcome Index (TOI: PWB + FWB + Lym): 0-116 - FACT-G Total (PWB + SWB + EWB + FWB): 0-108 - FACT-Lym Total (FACT-G + Lym): 0-168 In all cases, higher scores indicate better outcomes within the corresponding domain.
Baseline (BL), M3 change from baseline (CFB), M6 CFB, M9 CFB, M12 CFB, M18 CFB, M24 CFB, M36 CFB

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

Efterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

12. november 2018

Primær færdiggørelse (Faktiske)

24. november 2020

Studieafslutning (Faktiske)

28. maj 2025

Datoer for studieregistrering

Først indsendt

24. maj 2018

Først indsendt, der opfyldte QC-kriterier

13. juni 2018

Først opslået (Faktiske)

26. juni 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CCTL019E2202
  • 2017-004385-94 (EudraCT nummer)
  • 2023-508127-13-00 (Registry Identifier: EU CTIS)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Novartis er forpligtet til at dele med kvalificerede eksterne forskere, adgang til data på patientniveau og understøttende kliniske dokumenter fra kvalificerede undersøgelser. Disse anmodninger gennemgås og godkendes af et uafhængigt ekspertpanel på grundlag af videnskabelig fortjeneste. Alle opgivne data er anonymiseret for at respektere privatlivets fred for patienter, der har deltaget i forsøget i overensstemmelse med gældende love og regler.

Disse forsøgsdata er i øjeblikket tilgængelige i henhold til processen beskrevet på www.clinicalstudydatarequest.com.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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