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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
100 Years
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


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