Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05541328




Registration number
NCT05541328
Ethics application status
Date submitted
13/09/2022
Date registered
15/09/2022
Date last updated
15/09/2022

Titles & IDs
Public title
Comparison of Clinical Outcomes Among Patients Treated With Tisagenlecleucel
Scientific title
Comparison of Clinical Outcomes Among Patients Treated With Tisagenlecleucel in the JULIET Trial Versus a Real-world, Retrospective Cohort of Patients Treated With Standard of Care for Relapsed or Refractory Diffuse Large B-cell Lymphoma
Secondary ID [1] 0 0
CCTL019C2002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-cell 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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Tisagenlecleucel

Tisagenlecleucel therapy - The trial cohort is defined as the cohort of patients enrolled in JULIET who were assigned to receive tisagenlecleucel infusion

Standard of care - The real-world cohort is defined as the cohort of patients derived from the FHRD receiving SOC as the third line of therapy or later


Other interventions: Tisagenlecleucel
The trial cohort is defined as the cohort of patients enrolled in JULIET who were assigned to receive tisagenlecleucel infusion
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS): ITT population
Timepoint [1] 0 0
throughout the study, approximately 5 years
Primary outcome [2] 0 0
Overall survival (OS): FAS population
Timepoint [2] 0 0
throughout the study, approximately 5 years
Secondary outcome [1] 0 0
Overall response rate (ORR): ITT population
Timepoint [1] 0 0
throughout the study, approximately 5 years
Secondary outcome [2] 0 0
Overall response rate (ORR): FAS population
Timepoint [2] 0 0
throughout the study, approximately 5 years

Eligibility
Key inclusion criteria
Diagnosed with Non-Hodgkin lymphoma (International Classification of Diseases 9th revision
[ICD 9]: 200x, 202x or ICD 10th revision [ICD 10]: C82x, C83x, C84x, C85x, C86x, C88x,
C96x), as captured in the structured data on or after January 1, 2011 AND at least two
documented clinical visits in the Flatiron Health network on or after 01 January 2011.

AND has abstracted diagnosis date of DLBCL on or after January 1, 2011 AND received at
least three lines of therapy AND received rituximab AND received
anthracycline/anthracenedione AND has at least one 3L+ with prior exposure to rituximab and
prior exposure to at least one anthracycline/anthracenedione AND at least 18 years old at
index line start AND did not receive a clinical study drug in or prior to the earliest
eligible 3L+ line (this represented Flatiron data delivered as part of the 3L + DLBCL
Spotlight study) AND with at least 180 days of potential follow-up from index date to
Flatiron data cutoff AND relapsed or refractory disease after = 1 lines of therapy AND with
ECOG performance status of 0-1 (or missing) within 30 days prior to the index date AND with
adequate renal function defined as: serum creatinine of = 1.5 x ULN or eGFR = 60
mL/min/1.73 m2 (or missing) AND with adequate liver function defined as: ALT = 5 x ULN and
bilirubin = 2.0 mg/dl (or missing) AND with adequate bone marrow reserve defined as: ANC >
1,000/mm3 and ALC = 300/mm3 and platelets = 50,000/mm3 and hemoglobin > 8.0 g/dl (or
missing) AND confirmation of index line of therapy via abstraction.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclude patients who received anti-CD19, CAR-T/gene therapy or allogenic stem cell
transplant prior to index date AND exclude patients who received CAR-T/gene therapy except
Yescarta, clinical study drug or autologous hematopoietic stem cell transplant as the index
line of therapy AND exclude patients with CNS involvement on or prior to index date AND
exclude HIV positive patients on or prior to index date AND exclude patients with
myocardial infarction within 6 months prior to index date AND exclude patients with
previous or concurrent malignancy on or prior to the index date AND exclude patients with
evidence of pregnancy on or prior to index date AND exclude patients with T-cell
rich/histiocyte rich large B-cell lymphoma (THRBCL), primary mediastinal B-cell lymphoma
(PMBCL), EBV positive DLBCL, or Burkitt lymphoma

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/02/2021
Sample size
Target
Accrual to date
Final
169
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a non-interventional, retrospective cohort study using the Flatiron Health Research
Database (FHRD) and data from the single-arm phase II JULIET clinical trial (NCT02445248).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05541328
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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