Clinical trial NCT05541328: Comparison of Clinical Outcomes Among Patients Treated With Tisagenlecleucel
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-cell Lymphoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-09-15
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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).

Detailed description: JULIET is a single-arm, open-label, multi-center phase II study of tisagenlecleucel involving adult patients with r/r DLBCL who were ineligible for or had disease progression after autologous hematopoietic stem-cell transplantation.

Patients enrolled in JULIET will be referred to as the trial cohort in this study. Outcomes observed in the trial cohort will be compared against a cohort of patients receiving standard of care, defined as the real-world cohort in this study. The real-world cohort will be derived from the FHRD by applying relevant JULIET trial inclusion and exclusion criteria that are feasible to apply in the FHRD.

Eligibility criteria: 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.

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

Primary outcomes:
measure: Overall survival (OS): ITT population
timeFrame: throughout the study, approximately 5 years
measure: Overall survival (OS): FAS population
timeFrame: throughout the study, approximately 5 years
Secondary outcomes:
measure: Overall response rate (ORR): ITT population
timeFrame: throughout the study, approximately 5 years
measure: Overall response rate (ORR): FAS population
timeFrame: throughout the study, approximately 5 years
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: