난치성 또는 재발성 여포성 림프종 성인 환자에서 Tisagenlecleucel의 효능 및 안전성 (ELARA)
2026년 7월 7일 업데이트: Novartis Pharmaceuticals
불응성 또는 재발성 여포성 림프종 성인 환자에서 Tisagenlecleucel(CTL019)의 효능 및 안전성을 결정하기 위한 II상, 단일군, 다기관 공개 라벨 시험
이것은 재발성 또는 불응성 FL이 있는 성인 환자에서 tisagenlecleucel의 효능과 안전성을 결정하기 위한 다기관 제2상 연구입니다.
연구 개요
상세 설명
이 단일군, 공개 라벨 연구는 다음과 같은 순차적인 단계를 거쳤습니다: 스크리닝, 전처리, 치료 및 추적.
치료 전 단계에서 환자는 가교 요법(선택 사항) 및 림프구 고갈(LD) 화학 요법을 받을 수 있습니다.
치료 및 추적 단계에는 티사젠렉류셀 주입과 최소 24개월 동안의 안전성 및 효능 추적이 포함되었습니다.
티사젠렉류셀 주입을 받은 모든 환자는 3개월마다 추가 생존 추적을 시행하여 생존 여부를 확인하였다.
연구 유형
중재적
등록 (실제)
98
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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North Holland
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Amsterdam, North Holland, 네덜란드, 1081 HV
- Novartis Investigative Site
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Norway
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Oslo, Norway, 노르웨이, 0310
- Novartis Investigative Site
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Ulm, 독일, 89081
- Novartis Investigative Site
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Bavaria
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Munich, Bavaria, 독일, 81377
- Novartis Investigative Site
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North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, 독일, 50937
- Novartis Investigative Site
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California
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Duarte, California, 미국, 91010 3000
- City of Hope National Medical Center
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San Francisco, California, 미국, 94143
- UCSF Medical Center
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Florida
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Tampa, Florida, 미국, 33612
- H Lee Moffitt Cancer Center and Research Institute
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Illinois
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Chicago, Illinois, 미국, 60637
- Uni of Chi Medi Ctr Hema and Onco
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Kansas
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Kansas City, Kansas, 미국, 66160
- Univ of Kansas Hosp and Med Ctr
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Michigan
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Ann Arbor, Michigan, 미국, 48109 5271
- Michigan Med University of Michigan
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health Sciences University
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania Clinical
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Texas
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Houston, Texas, 미국, 77030
- MD Anderson Cancer Center
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Ghent, 벨기에, 9000
- Novartis Investigative Site
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Madrid, 스페인, 28041
- Novartis Investigative Site
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Seville, 스페인, 41013
- Novartis Investigative Site
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London, 영국, SE5 9RS
- Novartis Investigative Site
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West Midlands
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Birmingham, West Midlands, 영국, B15 2TH
- Novartis Investigative Site
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Linz, 오스트리아, 4020
- Novartis Investigative Site
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BO
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Bologna, BO, 이탈리아, 40138
- Novartis Investigative Site
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MI
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Milan, MI, 이탈리아, 20132
- Novartis Investigative Site
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Fukuoka, 일본, 8128582
- Novartis Investigative Site
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Hokkaido
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Sapporo, Hokkaido, 일본, 060-8648
- Novartis Investigative Site
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Miyagi
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Sendai, Miyagi, 일본, 9808574
- Novartis Investigative Site
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Paris, 프랑스, 75475
- Novartis Investigative Site
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Pierre-Bénite, 프랑스, 69495
- Novartis Investigative Site
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Herston, 호주, QLD 4006
- Novartis Investigative Site
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New South Wales
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Camperdown, New South Wales, 호주, 2050
- Novartis Investigative Site
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Victoria
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Melbourne, Victoria, 호주, 3000
- Novartis Investigative Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 난치성 또는 재발성 여포성 림프종(등급 1, 2, 3A)
- 스크리닝 시 방사선학적으로 측정 가능한 질병
제외 기준:
- 조직학적 변형의 증거
- 여포 림프종 등급 3B
- 이전 항-CD19 요법
- 이전 유전자 치료
- 사전 입양 T 세포 요법
- 이전 동종 조혈모세포 이식
- 악성 종양에 의한 활성 CNS 침범
다른 프로토콜 정의 포함/제외 기준이 적용될 수 있습니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: CTL019
티사젠류클루셀을 주입받은 모든 환자.
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Tisagenlecleucel은 단일 주입입니다.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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IRC(Independent Review Committee) 평가에 따른 완전 응답률(CRR)
기간: 일년
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완전 반응률은 tisagenlecleucel 주입부터 진행성 질환 또는 새로운 항암 요법 시작까지 기록된 완전 반응(CR)의 최고 종합 반응(BOR)을 가진 참가자의 백분율로 정의되었습니다.
CRR은 독립 검토 위원회(IRC)에서 결정했으며 Lugano 2014 분류 응답 기준을 기반으로 했습니다.
방사선 반응은 먼저 Lugano 2014 기준에 따라 CT 및 PET 연구에서 얻습니다.
CT 반응은 지표/비지표/새로운 병변 및 비장 길이의 해부학적 측정을 기반으로 합니다.
가능한 반응 결과는 완전 반응(CR), 부분 반응(PR), 안정 질환(SD) 또는 진행성 질환(PD)입니다.
5점 척도(5PS) 또는 Deauville 점수를 기반으로 한 PET 반응.
PET 반응에 대한 가능한 결과는 완전 대사 반응(CMR), 부분 대사 반응(PMR), 무대사 반응(NMR) 또는 진행성 대사 질환(PMD)입니다.
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일년
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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IRC 평가에 따른 전체 응답률(ORR)
기간: 일년
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전체 반응률은 완전 반응(CR) 또는 부분 반응(PR)의 최상의 전체 질병 반응을 보이는 참가자의 백분율로 정의됩니다.
응답은 Lugano 2014 분류 응답 기준에 따라 평가되었습니다.
방사선 반응은 먼저 Lugano 2014 기준에 따라 CT 및 PET 연구에서 얻습니다.
CT 반응은 지표/비지표/새로운 병변 및 비장 길이의 해부학적 측정을 기반으로 합니다.
가능한 반응 결과는 완전 반응(CR), 부분 반응(PR), 안정 질환(SD) 또는 진행성 질환(PD)입니다.
5점 척도(5PS) 또는 Deauville 점수를 기반으로 한 PET 반응.
PET 반응에 대한 가능한 결과는 완전 대사 반응(CMR), 부분 대사 반응(PMR), 무대사 반응(NMR) 또는 진행성 대사 질환(PMD)입니다.
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일년
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Duration of Response (DOR) Per IRC Assessment
기간: approx. 60 months
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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.
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approx. 60 months
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Duration of Response (DOR) for Complete Response (CR) Only Per IRC Assessment
기간: approx. 60 months
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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.
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approx. 60 months
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Progression Free Survival (PFS) Per IRC Assessment
기간: up to 61.7 months
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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.
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up to 61.7 months
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Overall Survival (OS)
기간: up to 65.8 months
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Overall Survival is the time from tisagenlecleucel infusion to death due to any cause.
OS was estimated using the Kaplan-Meier method.
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up to 65.8 months
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Tisagenlecleucel Transgene Concentration Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) Method, by Clinical Response Per IRC Assessment
기간: Month 60 (peripheral blood), Month 6 (bone marrow)
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This is the summary of cellular kinetic concentrations for tisagenlecleucel (CTL019) transgene levels in peripheral blood and bone marrow following infusion.
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Month 60 (peripheral blood), Month 6 (bone marrow)
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Cmax; Cellular Kinetic Parameter of Tisagenlecleucel Transgene Levels by qPCR, Based on Clinical Response IRC Assessment
기간: up to 60 months after infusion
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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.
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up to 60 months after infusion
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Tmax; Cellular Kinetic Parameter of Tisagenlecleucel Transgene Levels by qPCR, Based on Clinical Response by IRC Assessment
기간: up to 60 months after infusion
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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.
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up to 60 months after infusion
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AUC0-28d and AUC0-84d; Cellular Kinetic Parameter of Tisagenlecleucel Transgene Levels by qPCR, Based on Clinical Response by IRC Assessment
기간: 0 to 28 days after infusion, 0 to 84 days after infusion
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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.
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0 to 28 days after infusion, 0 to 84 days after infusion
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AUC0-28d and AUC0-84d; Cellular Kinetic Parameter for Tisagenlecleucel by Flow Cytometry, Based on Clinical Response by IRC Assessment
기간: AUC0-28d: from time of infusion to 28 days post-dose; AUC0-84d: from time of infusion to 84 days post-infusion
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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.
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AUC0-28d: from time of infusion to 28 days post-dose; AUC0-84d: from time of infusion to 84 days post-infusion
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Cmax; Cellular Kinetic Parameter for Tisagenlecleucel by Flow Cytometry, Based on Clinical Response by IRC Assessment
기간: From pre-dose until 60 months after infusion
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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.
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From pre-dose until 60 months after infusion
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Summary of Exposure of CD3+ Tisagenlecleucel Cells in Peripheral Blood for Tmax
기간: From pre-dose until 60 months after infusion
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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.
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From pre-dose until 60 months after infusion
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Humoral Immunogenicity: Number of Participants With Anti-mCAR19 Antibodies, Per IRC Assessment
기간: at any time post-baseline, up to 24 months post-infusion
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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).
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at any time post-baseline, up to 24 months post-infusion
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Cellular Immunogenicity: Percentage of Interferon Gamma (IFNg+) Cells by Flow Cytometry Per IRC Assessment
기간: pre-infusion (pre-Lymph depletion evaluation), 24 months post-infusion
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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
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Summary Scores of Patient-reported Outcome (PRO) Measured by SF-36v2 Quality of Life Questionnaire by Visit
기간: Baseline (BL) Month (M) 3, M3, M6, M9, M12, M18, M24
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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.
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Baseline (BL) Month (M) 3, M3, M6, M9, M12, M18, M24
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Summary Scores of PRO Measured by SF-36v2 Quality of Life Questionnaire Reported by Change From Baseline
기간: Change from baseline (CFB) M3, CFB M6, CFB M9, CFB M12, CFB M18, CFB M24
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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.
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Change from baseline (CFB) M3, CFB M6, CFB M9, CFB M12, CFB M18, CFB M24
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Health Status Measured by EQ-5D-3L Questionnaire
기간: Baseline (BL), Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 36
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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.
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Baseline (BL), Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 36
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Summary Scores of PRO Measured by EQ-VAS Quality of Life Questionnaire by Visit
기간: Baseline (BL) Month (M) 3, M6, M9, M12, M18, M24, M36
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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."
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Baseline (BL) Month (M) 3, M6, M9, M12, M18, M24, M36
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Summary Scores of PRO Measured by EQ-VAS Quality of Life Questionnaire Reported by Change From Baseline
기간: Baseline (BL), M3 change from baseline (CFB), M6 CFB, M9 CFB, M12 CFB, M18 CFB, M24 CFB, M36 CFB
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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
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Baseline (BL), M3 change from baseline (CFB), M6 CFB, M9 CFB, M12 CFB, M18 CFB, M24 CFB, M36 CFB
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Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire
기간: Baseline (BL) Month (M) 3, M6, M9, M12, M18, M24, M36
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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.
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Baseline (BL) Month (M) 3, M6, M9, M12, M18, M24, M36
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Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire Reported by Change From Baseline
기간: Baseline (BL), M3 change from baseline (CFB), M6 CFB, M9 CFB, M12 CFB, M18 CFB, M24 CFB, M36 CFB
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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.
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Baseline (BL), M3 change from baseline (CFB), M6 CFB, M9 CFB, M12 CFB, M18 CFB, M24 CFB, M36 CFB
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Novartis Pharmaceuticals, Novartis Pharmaceuticals
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Salles G, Schuster SJ, Dreyling M, Fischer L, Kuruvilla J, Patten PEM, von Tresckow B, Smith SM, Jimenez-Ubieto A, Davis KL, Anjos C, Chu J, Zhang J, Lobetti Bodoni C, Thieblemont C, Fowler NH, Dickinson M, Martinez-Lopez J, Wang Y, Link BK. Efficacy comparison of tisagenlecleucel vs usual care in patients with relapsed or refractory follicular lymphoma. Blood Adv. 2022 Nov 22;6(22):5835-5843. doi: 10.1182/bloodadvances.2022008150.
- Fowler NH, Dickinson M, Dreyling M, Martinez-Lopez J, Kolstad A, Butler J, Ghosh M, Popplewell L, Chavez JC, Bachy E, Kato K, Harigae H, Kersten MJ, Andreadis C, Riedell PA, Ho PJ, Perez-Simon JA, Chen AI, Nastoupil LJ, von Tresckow B, Ferreri AJM, Teshima T, Patten PEM, McGuirk JP, Petzer AL, Offner F, Viardot A, Zinzani PL, Malladi R, Zia A, Awasthi R, Masood A, Anak O, Schuster SJ, Thieblemont C. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial. Nat Med. 2022 Feb;28(2):325-332. doi: 10.1038/s41591-021-01622-0. Epub 2021 Dec 17.
- Dreyling M, Fowler NH, Dickinson M, Martinez-Lopez J, Kolstad A, Butler J, Ghosh M, Popplewell L, Chavez JC, Bachy E, Kato K, Harigae H, Kersten MJ, Andreadis C, Riedell PA, Ho PJ, Perez-Simon JA, Chen AI, Nastoupil LJ, von Tresckow B, Maria Ferreri AJ, Teshima T, Patten PEM, McGuirk JP, Petzer AL, Offner F, Viardot A, Zinzani PL, Malladi R, Paule I, Zia A, Awasthi R, Han X, Germano D, O'Donovan D, Ramos R, Maier HJ, Masood A, Thieblemont C, Schuster SJ. Durable response after tisagenlecleucel in adults with relapsed/refractory follicular lymphoma: ELARA trial update. Blood. 2024 Apr 25;143(17):1713-1725. doi: 10.1182/blood.2023021567.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 11월 12일
기본 완료 (실제)
2020년 11월 24일
연구 완료 (실제)
2025년 5월 28일
연구 등록 날짜
최초 제출
2018년 5월 24일
QC 기준을 충족하는 최초 제출
2018년 6월 13일
처음 게시됨 (실제)
2018년 6월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 7일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CCTL019E2202
- 2017-004385-94 (EudraCT 번호)
- 2023-508127-13-00 (레지스트리 식별자: EU CTIS)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Novartis는 자격을 갖춘 외부 연구원과 공유하고, 환자 수준 데이터에 액세스하고, 적격 연구의 임상 문서를 지원하기 위해 최선을 다하고 있습니다. 이러한 요청은 과학적 가치를 바탕으로 독립적인 전문가 패널이 검토하고 승인합니다. 제공된 모든 데이터는 해당 법률 및 규정에 따라 시험에 참여한 환자의 개인 정보를 존중하기 위해 익명으로 처리됩니다.
이 시험 데이터는 현재 www.clinicalstudydatarequest.com에 설명된 프로세스에 따라 사용할 수 있습니다.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .