Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
ELARA
A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients With Refractory or Relapsed Follicular Lymphoma
3 other identifiers
interventional
98
11 countries
30
Brief Summary
This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2018
Longer than P75 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedStudy Start
First participant enrolled
November 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2020
CompletedResults Posted
Study results publicly available
July 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2025
CompletedOctober 7, 2025
September 1, 2025
2 years
May 24, 2018
June 24, 2022
September 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Response Rate (CRR) Per Independent Review Committee (IRC) Assessment
Complete response rate was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) recorded from tisagenlecleucel infusion until progressive disease or start of new anticancer therapy, whichever came first. CRR was determined by an independent review committee (IRC) and was based on Lugano 2014 classification response criteria. The radiological response is first obtained from CT and PET studies according to the Lugano 2014 criteria. CT response is based on anatomical measurements of index/non-index/new lesions and spleen length. The possible response outcomes are complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). PET response based on a 5-point scale (5PS) or Deauville score. The possible outcomes for PET response are complete metabolic response (CMR), partial metabolic response (PMR), no metabolic response (NMR), or progressive metabolic disease (PMD).
1 year
Secondary Outcomes (17)
Overall Response Rate (ORR) Per IRC Assessment
1 year
Duration of Response (DOR) Per IRC
1 year
Progression Free Survival (PFS)
2 years
Overall Survival (OS)
2 years
Tisagenlecleucel Transgene Concentration
2 years
- +12 more secondary outcomes
Study Arms (1)
CTL019
EXPERIMENTALAll patients who received tisagenlecleucel infusion.
Interventions
Eligibility Criteria
You may qualify if:
- Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)
- Radiographically measurable disease at screening
You may not qualify if:
- Evidence of histologic transformation
- Follicular Lymphoma Grade 3B
- Prior anti-CD19 therapy
- Prior gene therapy
- Prior adoptive T cell therapy
- Prior allogeneic hematopoietic stem cell transplant
- Active CNS involvement by malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
City of Hope National Medical Center
Duarte, California, 91010 3000, United States
UCSF Medical Center
San Francisco, California, 94143, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Uni of Chi Medi Ctr Hema and Onco
Chicago, Illinois, 60637, United States
Univ of Kansas Hosp and Med Ctr
Kansas City, Kansas, 66160, United States
Michigan Med University of Michigan
Ann Arbor, Michigan, 48109 5271, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
University of Pennsylvania Clinical
Philadelphia, Pennsylvania, 19104, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Novartis Investigative Site
Camperdown, New South Wales, 2050, Australia
Novartis Investigative Site
Melbourne, Victoria, 3000, Australia
Novartis Investigative Site
Herston, QLD 4006, Australia
Novartis Investigative Site
Linz, 4020, Austria
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Paris, 75475, France
Novartis Investigative Site
Pierre-Bénite, 69495, France
Novartis Investigative Site
Munich, Bavaria, 81377, Germany
Novartis Investigative Site
Cologne, 50937, Germany
Novartis Investigative Site
Ulm, 89081, Germany
Novartis Investigative Site
Bologna, BO, 40138, Italy
Novartis Investigative Site
Milan, MI, 20132, Italy
Novartis Investigative Site
Fukuoka, Fukuoka, 812-8582, Japan
Novartis Investigative Site
Sapporo, Hokkaido, 060 8648, Japan
Novartis Investigative Site
Sendai, Miyagi, 980 8574, Japan
Novartis Investigative Site
Amsterdam, North Holland, 1081 HV, Netherlands
Amsterdam UMC, locatie AMC
Amsterdam, 1105 AZ, Netherlands
Novartis Investigative Site
Oslo, 0310, Norway
Novartis Investigative Site
Seville, Andalusia, 41013, Spain
Novartis Investigative Site
Madrid, 28041, Spain
Novartis Investigative Site
Birmingham, B15 2TH, United Kingdom
Novartis Investigative Site
London, SE5 9RS, United Kingdom
Related Publications (3)
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.
PMID: 38194692DERIVEDSalles 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.
PMID: 35973192DERIVEDFowler 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.
PMID: 34921238DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2018
First Posted
June 26, 2018
Study Start
November 12, 2018
Primary Completion
November 24, 2020
Study Completion
May 28, 2025
Last Updated
October 7, 2025
Results First Posted
July 22, 2022
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.