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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03568461
Registration number
NCT03568461
Ethics application status
Date submitted
24/05/2018
Date registered
26/06/2018
Titles & IDs
Public title
Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
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Scientific title
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
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Secondary ID [1]
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2017-004385-94
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Secondary ID [2]
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CCTL019E2202
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Universal Trial Number (UTN)
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Trial acronym
ELARA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - tisagenlecleucel
Experimental: CTL019 - All patients who received tisagenlecleucel infusion.
Treatment: Other: tisagenlecleucel
Tisagenlecleucel is single infusion.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Complete Response Rate (CRR) Per Independent Review Committee (IRC) Assessment
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Assessment method [1]
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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).
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Overall Response Rate (ORR) Per IRC Assessment
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Assessment method [1]
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Overall response rate is defined as the percentage of participants with a best overall disease response of complete response (CR) or partial response (PR). Response was evaluated per 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).
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Timepoint [1]
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1 year
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Secondary outcome [2]
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Duration of Response (DOR) Per IRC
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Assessment method [2]
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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).
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Timepoint [2]
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1 year
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Secondary outcome [3]
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Progression Free Survival (PFS)
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Assessment method [3]
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Time from tisagenlecleucel infusion to first documented disease progression or death due to any cause
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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Time from tisagenlecleucel infusion to death due to any cause
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Timepoint [4]
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2 years
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Secondary outcome [5]
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Tisagenlecleucel Transgene Concentration
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Assessment method [5]
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Transgene concentration as detected by qPCR in target tissue
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Timepoint [5]
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2 years
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Secondary outcome [6]
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Cmax; Cellular Kinetic Parameter of Tisagenlecleucel
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Assessment method [6]
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The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (% or copies/ µg)
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Timepoint [6]
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2 years
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Secondary outcome [7]
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Tmax; Cellular Kinetic Parameter of Tisagenlecleucel
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Assessment method [7]
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The time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)
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Timepoint [7]
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2 years
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Secondary outcome [8]
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AUC0-28; Cellular Kinetic Parameter of Tisagenlecleucel
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Assessment method [8]
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The AUC from time zero to day 28, in peripheral blood (%\*days or days\*copies/ µg)
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Timepoint [8]
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2 years
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Secondary outcome [9]
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AUC0-84d; Cellular Kinetic Parameter of Tisagenlecleucel
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Assessment method [9]
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The AUC from time zero to day 84, in peripheral blood (%\*days or days\*copies/ µg)
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Timepoint [9]
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2 years
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Secondary outcome [10]
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T1/2; Cellular Kinetic Parameter of Tisagenlecleucel
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Assessment method [10]
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The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood
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Timepoint [10]
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2 years
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Secondary outcome [11]
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Tlast; Cellular Kinetic Parameter of Tisagenlecleucel
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Assessment method [11]
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The last observed measureable timepoint after dose administration
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Timepoint [11]
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2 years
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Secondary outcome [12]
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Summary of Exposure of CD3+ Tisagenlecleucel Cells in Peripheral Blood
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Assessment method [12]
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In vivo cellular kinetics of CD3+ tisagenlecleucel cells detected by flow cytometry
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Timepoint [12]
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2 years
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Secondary outcome [13]
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Humoral Immunogenicity
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Assessment method [13]
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Antibody titers specific to the tisagenlecleucel molecule prior to and following infusion.
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Timepoint [13]
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2 years
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Secondary outcome [14]
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Cellular Immunogenicity
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Assessment method [14]
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Presence of T lymphocytes activated by the tisagenlecleucel protein
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Timepoint [14]
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2 years
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Secondary outcome [15]
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Summary Scores of PRO Measured by SF-36v2 Quality of Life Questionnaire
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Assessment method [15]
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Effect of tisagenlecleucel therapy on Patient reported outcomes
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Timepoint [15]
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2 years
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Secondary outcome [16]
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Summary Scores of PRO Measured by EQ-5D-3L Quality of Life Questionnaire
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Assessment method [16]
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Effect of tisagenlecleucel therapy on Patient reported outcomes
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Timepoint [16]
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2 years
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Secondary outcome [17]
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Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire
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Assessment method [17]
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Effect of tisagenlecleucel therapy on Patient reported outcomes
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Timepoint [17]
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2 years
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Eligibility
Key inclusion criteria
* Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)
* Radiographically measurable disease at screening
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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
Other protocol-defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
22/05/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
98
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Herston
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Recruitment hospital [2]
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Novartis Investigative Site - Melbourne
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Recruitment hospital [3]
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Novartis Investigative Site - Camperdown
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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NSW - Camperdown
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
0
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United States of America
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State/province [3]
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Illinois
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Country [4]
0
0
United States of America
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State/province [4]
0
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Kansas
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Country [5]
0
0
United States of America
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State/province [5]
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Michigan
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Country [6]
0
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United States of America
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State/province [6]
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Oregon
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Country [7]
0
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United States of America
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State/province [7]
0
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Pennsylvania
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Country [8]
0
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United States of America
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State/province [8]
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Texas
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Country [9]
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Austria
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State/province [9]
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Linz
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Country [10]
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Belgium
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State/province [10]
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Gent
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Country [11]
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France
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State/province [11]
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Paris 10
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Country [12]
0
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France
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State/province [12]
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Pierre Benite
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Country [13]
0
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Germany
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State/province [13]
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Koeln
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Country [14]
0
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Germany
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State/province [14]
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Muenchen
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Country [15]
0
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Germany
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State/province [15]
0
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Ulm
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Country [16]
0
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Italy
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State/province [16]
0
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BO
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Country [17]
0
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Italy
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State/province [17]
0
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MI
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Country [18]
0
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Japan
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State/province [18]
0
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Fukuoka
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Country [19]
0
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Japan
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State/province [19]
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Hokkaido
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Country [20]
0
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Japan
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State/province [20]
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Miyagi
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Country [21]
0
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Netherlands
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State/province [21]
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Amsterdam
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Country [22]
0
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Norway
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State/province [22]
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Oslo
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Country [23]
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Spain
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State/province [23]
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Andalucia
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Country [24]
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Spain
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State/province [24]
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Madrid
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Country [25]
0
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United Kingdom
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State/province [25]
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Birmingham
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Country [26]
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United Kingdom
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State/province [26]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03568461
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/61/NCT03568461/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/61/NCT03568461/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03568461