Comparison of Clinical Outcomes Among Patients Treated With Tisagenlecleucel

NCT05541328 | Completed

• 1 other identifier: CCTL019C2002
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

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).

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS): ITT population

  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.

  throughout the study, approximately 5 years

• Overall survival (OS): FAS population

  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.

  throughout the study, approximately 5 years

Secondary Outcomes (2)

• Overall response rate (ORR): ITT population

  throughout the study, approximately 5 years

• Overall response rate (ORR): FAS population

  throughout the study, approximately 5 years

Study Arms (2)

Tisagenlecleucel therapy

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

Other: Tisagenlecleucel

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

Interventions

Tisagenlecleucel OTHER

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

Tisagenlecleucel therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

tisagenlecleucel

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 15, 2022
• Study Start: February 3, 2020
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

US (1)