Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03568461
Registration number
NCT03568461
Ethics application status
Date submitted
24/05/2018
Date registered
26/06/2018
Date last updated
30/01/2024
Titles & IDs
Public title
Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
Query!
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
Query!
Secondary ID [1]
0
0
2017-004385-94
Query!
Secondary ID [2]
0
0
CCTL019E2202
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ELARA
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - tisagenlecleucel
Experimental: CTL019 - All patients who received tisagenlecleucel infusion.
Other interventions: tisagenlecleucel
Tisagenlecleucel is single infusion.
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Complete Response Rate (CRR) Per Independent Review Committee (IRC) Assessment
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
1 year
Query!
Secondary outcome [1]
0
0
Overall Response Rate (ORR) Per IRC Assessment
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
1 year
Query!
Secondary outcome [2]
0
0
Duration of Response (DOR) Per IRC
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
1 year
Query!
Secondary outcome [3]
0
0
Progression Free Survival (PFS)
Query!
Assessment method [3]
0
0
Time from tisagenlecleucel infusion to first documented disease progression or death due to any cause
Query!
Timepoint [3]
0
0
2 years
Query!
Secondary outcome [4]
0
0
Overall Survival (OS)
Query!
Assessment method [4]
0
0
Time from tisagenlecleucel infusion to death due to any cause
Query!
Timepoint [4]
0
0
2 years
Query!
Secondary outcome [5]
0
0
Tisagenlecleucel Transgene Concentration
Query!
Assessment method [5]
0
0
Transgene concentration as detected by qPCR in target tissue
Query!
Timepoint [5]
0
0
2 years
Query!
Secondary outcome [6]
0
0
Cmax; Cellular Kinetic Parameter of Tisagenlecleucel
Query!
Assessment method [6]
0
0
The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (% or copies/ µg)
Query!
Timepoint [6]
0
0
2 years
Query!
Secondary outcome [7]
0
0
Tmax; Cellular Kinetic Parameter of Tisagenlecleucel
Query!
Assessment method [7]
0
0
The time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)
Query!
Timepoint [7]
0
0
2 years
Query!
Secondary outcome [8]
0
0
AUC0-28; Cellular Kinetic Parameter of Tisagenlecleucel
Query!
Assessment method [8]
0
0
The AUC from time zero to day 28, in peripheral blood (%*days or days*copies/ µg)
Query!
Timepoint [8]
0
0
2 years
Query!
Secondary outcome [9]
0
0
AUC0-84d; Cellular Kinetic Parameter of Tisagenlecleucel
Query!
Assessment method [9]
0
0
The AUC from time zero to day 84, in peripheral blood (%*days or days*copies/ µg)
Query!
Timepoint [9]
0
0
2 years
Query!
Secondary outcome [10]
0
0
T1/2; Cellular Kinetic Parameter of Tisagenlecleucel
Query!
Assessment method [10]
0
0
The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood
Query!
Timepoint [10]
0
0
2 years
Query!
Secondary outcome [11]
0
0
Tlast; Cellular Kinetic Parameter of Tisagenlecleucel
Query!
Assessment method [11]
0
0
The last observed measureable timepoint after dose administration
Query!
Timepoint [11]
0
0
2 years
Query!
Secondary outcome [12]
0
0
Summary of Exposure of CD3+ Tisagenlecleucel Cells in Peripheral Blood
Query!
Assessment method [12]
0
0
In vivo cellular kinetics of CD3+ tisagenlecleucel cells detected by flow cytometry
Query!
Timepoint [12]
0
0
2 years
Query!
Secondary outcome [13]
0
0
Humoral Immunogenicity
Query!
Assessment method [13]
0
0
Antibody titers specific to the tisagenlecleucel molecule prior to and following infusion.
Query!
Timepoint [13]
0
0
2 years
Query!
Secondary outcome [14]
0
0
Cellular Immunogenicity
Query!
Assessment method [14]
0
0
Presence of T lymphocytes activated by the tisagenlecleucel protein
Query!
Timepoint [14]
0
0
2 years
Query!
Secondary outcome [15]
0
0
Summary Scores of PRO Measured by SF-36v2 Quality of Life Questionnaire
Query!
Assessment method [15]
0
0
Effect of tisagenlecleucel therapy on Patient reported outcomes
Query!
Timepoint [15]
0
0
2 years
Query!
Secondary outcome [16]
0
0
Summary Scores of PRO Measured by EQ-5D-3L Quality of Life Questionnaire
Query!
Assessment method [16]
0
0
Effect of tisagenlecleucel therapy on Patient reported outcomes
Query!
Timepoint [16]
0
0
2 years
Query!
Secondary outcome [17]
0
0
Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire
Query!
Assessment method [17]
0
0
Effect of tisagenlecleucel therapy on Patient reported outcomes
Query!
Timepoint [17]
0
0
2 years
Query!
Eligibility
Key inclusion criteria
- Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)
- Radiographically measurable disease at screening
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
12/11/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
22/05/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
98
Query!
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Herston
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Melbourne
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - Camperdown
Query!
Recruitment postcode(s) [1]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [2]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [3]
0
0
NSW - Camperdown
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Illinois
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Kansas
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Michigan
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Oregon
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Pennsylvania
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Texas
Query!
Country [9]
0
0
Austria
Query!
State/province [9]
0
0
Linz
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Gent
Query!
Country [11]
0
0
France
Query!
State/province [11]
0
0
Paris 10
Query!
Country [12]
0
0
France
Query!
State/province [12]
0
0
Pierre Benite
Query!
Country [13]
0
0
Germany
Query!
State/province [13]
0
0
Koeln
Query!
Country [14]
0
0
Germany
Query!
State/province [14]
0
0
Muenchen
Query!
Country [15]
0
0
Germany
Query!
State/province [15]
0
0
Ulm
Query!
Country [16]
0
0
Italy
Query!
State/province [16]
0
0
BO
Query!
Country [17]
0
0
Italy
Query!
State/province [17]
0
0
MI
Query!
Country [18]
0
0
Japan
Query!
State/province [18]
0
0
Fukuoka
Query!
Country [19]
0
0
Japan
Query!
State/province [19]
0
0
Hokkaido
Query!
Country [20]
0
0
Japan
Query!
State/province [20]
0
0
Miyagi
Query!
Country [21]
0
0
Netherlands
Query!
State/province [21]
0
0
Amsterdam
Query!
Country [22]
0
0
Norway
Query!
State/province [22]
0
0
Oslo
Query!
Country [23]
0
0
Spain
Query!
State/province [23]
0
0
Andalucia
Query!
Country [24]
0
0
Spain
Query!
State/province [24]
0
0
Madrid
Query!
Country [25]
0
0
United Kingdom
Query!
State/province [25]
0
0
Birmingham
Query!
Country [26]
0
0
United Kingdom
Query!
State/province [26]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03568461
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03568461
Download to PDF