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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
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
Treatment: Other - tisagenlecleucel

Experimental: CTL019 - All patients who received tisagenlecleucel infusion.


Treatment: Other: tisagenlecleucel
Tisagenlecleucel is single infusion.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complete Response Rate (CRR) Per Independent Review Committee (IRC) Assessment
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Overall Response Rate (ORR) Per IRC Assessment
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Duration of Response (DOR) Per IRC
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Progression Free Survival (PFS)
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Tisagenlecleucel Transgene Concentration
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Cmax; Cellular Kinetic Parameter of Tisagenlecleucel
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Tmax; Cellular Kinetic Parameter of Tisagenlecleucel
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
AUC0-28; Cellular Kinetic Parameter of Tisagenlecleucel
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
AUC0-84d; Cellular Kinetic Parameter of Tisagenlecleucel
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
T1/2; Cellular Kinetic Parameter of Tisagenlecleucel
Timepoint [10] 0 0
2 years
Secondary outcome [11] 0 0
Tlast; Cellular Kinetic Parameter of Tisagenlecleucel
Timepoint [11] 0 0
2 years
Secondary outcome [12] 0 0
Summary of Exposure of CD3+ Tisagenlecleucel Cells in Peripheral Blood
Timepoint [12] 0 0
2 years
Secondary outcome [13] 0 0
Humoral Immunogenicity
Timepoint [13] 0 0
2 years
Secondary outcome [14] 0 0
Cellular Immunogenicity
Timepoint [14] 0 0
2 years
Secondary outcome [15] 0 0
Summary Scores of PRO Measured by SF-36v2 Quality of Life Questionnaire
Timepoint [15] 0 0
2 years
Secondary outcome [16] 0 0
Summary Scores of PRO Measured by EQ-5D-3L Quality of Life Questionnaire
Timepoint [16] 0 0
2 years
Secondary outcome [17] 0 0
Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire
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
Sex
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

Other protocol-defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
12/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/05/2025
Actual
Sample size
Target
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [2] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [3] 0 0
Novartis Investigative Site - Herston
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
NSW - Camperdown
Recruitment postcode(s) [3] 0 0
QLD 4006 - Herston
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 10
Country [12] 0 0
France
State/province [12] 0 0
Pierre Benite
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03568461