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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03568461




Registration number
NCT03568461
Ethics application status
Date submitted
24/05/2018
Date registered
26/06/2018
Date last updated
9/06/2020

Titles & IDs
Public title
Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
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
Secondary ID [1] 0 0
2017-004385-94
Secondary ID [2] 0 0
CCTL019E2202
Universal Trial Number (UTN)
Trial acronym
ELARA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - tisagenlecleucel

Experimental: CTL019 - tisagenlecleucel infusion


Other interventions: tisagenlecleucel
single infusion

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complete response rate (CRR) - CRR based on Lugano classification response criteria
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Overall response rate (ORR) - ORR, including complete response (CR) and partial response (PR)
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Duration of response (DOR) - Time from achievement of CR or PR to relapse or death due to follicular lymphoma
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Progression free survival (PFS) - Time from tisagenlecleucel infusion to first documented disease progression or death due to any cause
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Overall survival (OS) - Time from tisagenlecleucel infusion to death due to any cause
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
tisagenlecleucel transgene concentration - Transgene concentration as detected by qPCR in target tissue
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Cmax; cellular kinetic parameter of tisagenlecleucel - The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (% or copies/ µg)
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Tmax; cellular kinetic parameter of tisagenlecleucel - The time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
AUC0-28; cellular kinetic parameter of tisagenlecleucel - The AUC from time zero to day 28, in peripheral blood (%*days or days*copies/ µg)
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
AUC0-84d; cellular kinetic parameter of tisagenlecleucel - The AUC from time zero to day 84, in peripheral blood (%*days or days*copies/ µg)
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
T1/2; cellular kinetic parameter of tisagenlecleucel - The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood
Timepoint [10] 0 0
2 years
Secondary outcome [11] 0 0
Tlast; cellular kinetic parameter of tisagenlecleucel - The last observed measureable timepoint after dose administration
Timepoint [11] 0 0
2 years
Secondary outcome [12] 0 0
Summary of exposure of CD3+ tisagenlecleucel cells in peripheral blood - In vivo cellular kinetics of CD3+ tisagenlecleucel cells detected by flow cytometry
Timepoint [12] 0 0
2 years
Secondary outcome [13] 0 0
humoral immunogenicity - Antibody titers specific to the tisagenlecleucel molecule prior to and following infusion.
Timepoint [13] 0 0
2 years
Secondary outcome [14] 0 0
cellular immunogenicity - Presence of T lymphocytes activated by the tisagenlecleucel protein
Timepoint [14] 0 0
2 years
Secondary outcome [15] 0 0
Summary scores of PRO measured by SF-36v2 quality of life questionnaire - Effect of tisagenlecleucel therapy on Patient reported outcomes
Timepoint [15] 0 0
2 years
Secondary outcome [16] 0 0
Summary scores of PRO measured by EQ-5D-3L quality of life questionnaire - Effect of tisagenlecleucel therapy on Patient reported outcomes
Timepoint [16] 0 0
2 years
Secondary outcome [17] 0 0
Summary scores of PRO measured by FACT-Lym quality of life questionnaire - Effect of tisagenlecleucel therapy on Patient reported outcomes
Timepoint [17] 0 0
2 years

Eligibility
Key inclusion criteria
- Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)

- Radiographically measurable disease at screening
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [2] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [3] 0 0
Novartis Investigative Site - Camperdown
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
NSW - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Austria
State/province [9] 0 0
Linz
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
France
State/province [12] 0 0
Pierre Benite Cedex
Country [13] 0 0
Germany
State/province [13] 0 0
Koeln
Country [14] 0 0
Germany
State/province [14] 0 0
Muenchen
Country [15] 0 0
Germany
State/province [15] 0 0
Ulm
Country [16] 0 0
Italy
State/province [16] 0 0
BO
Country [17] 0 0
Italy
State/province [17] 0 0
MI
Country [18] 0 0
Japan
State/province [18] 0 0
Fukuoka
Country [19] 0 0
Japan
State/province [19] 0 0
Hokkaido
Country [20] 0 0
Japan
State/province [20] 0 0
Miyagi
Country [21] 0 0
Netherlands
State/province [21] 0 0
Amsterdam
Country [22] 0 0
Norway
State/province [22] 0 0
Oslo
Country [23] 0 0
Spain
State/province [23] 0 0
Andalucia
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Birmingham
Country [26] 0 0
United Kingdom
State/province [26] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03568461
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications