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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
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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
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Secondary ID [1]
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CCTL019C2002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival (OS): ITT population
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Assessment method [1]
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To evaluate the efficacy of tisagenlecleucel therapy as compared to the current SOC as measured by overall survival (OS) among patients with r/r DLBCL and treated with at least two prior lines of systemic therapy.
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Timepoint [1]
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throughout the study, approximately 5 years
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Primary outcome [2]
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Overall survival (OS): FAS population
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Assessment method [2]
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To evaluate the efficacy of tisagenlecleucel therapy as compared to the current SOC as measured by overall survival (OS) among patients with r/r DLBCL and treated with at least two prior lines of systemic therapy.
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Timepoint [2]
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throughout the study, approximately 5 years
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Secondary outcome [1]
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Overall response rate (ORR): ITT population
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Assessment method [1]
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To evaluate the efficacy of tisagenlecleucel therapy as compared to the current SOC as measured by overall response rate (ORR), which includes complete response (CR) and partial response (PR), among patients with r/r DLBCL and treated with at least two prior lines of systemic therapy.
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Timepoint [1]
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throughout the study, approximately 5 years
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Secondary outcome [2]
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Overall response rate (ORR): FAS population
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Assessment method [2]
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To evaluate the efficacy of tisagenlecleucel therapy as compared to the current SOC as measured by overall response rate (ORR), which includes complete response (CR) and partial response (PR), among patients with r/r DLBCL and treated with at least two prior lines of systemic therapy.
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Timepoint [2]
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throughout the study, approximately 5 years
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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.
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/02/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/02/2021
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Sample size
Target
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Accrual to date
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Final
169
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New Jersey
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05541328
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Trial related presentations / publications
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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
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05541328
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