A Study to Evaluate the Therapeutic Benefit of Tisagenlecleucel Compared to Existing Standard of Care in German Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Completed

• Conditions: Diffuse Large B-Cell Lymphoma

• Registration Number: NCT07103486
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The aim of this study was to evaluate the therapeutic benefit of tisagenlecleucel compared to the existing standard of care in adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). For tisagenlecleucel patients, patient-level data from the JULIET study (CTL019C2201) was used. Data for patients treated with the appropriate comparator therapy (ACT) in German routine care was collected via chart review by 8 medical centers in Germany. The medical charts provided data on adult patients at the time of the qualifying treatments in the time period from approximately 2010 to 2017 with the longest possible follow-up phases (up to 5 years, but only until December 31, 2020).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to approximately 5 years	For the external control and tisagenelcleucel FAS groups: OS was defined as the time from the date of treatment start to the date of death due to any cause and censored otherwise.; For the tisagenelcleucel ITT group: OS was defined as the time from the date of enrollment to the date of death due to any cause and censored otherwise.
Progression-free Survival (PFS)	Up to approximately 5 years	For the external control and tisagenelcleucel FAS groups: PFS was defined as the time from the date of treatment start to the date of first documented disease progression or death due to any cause and censored otherwise.; For the tisagenelcleucel ITT group: PFS was defined as the time from the date of enrollment to the date of first documented disease progression or death due to any cause and censored otherwise.
Event-free Survival (EFS)	Up to approximately 5 years	For the external control and tisagenelcleucel FAS groups: EFS was defined as the time from the date of treatment start to the date of first documented disease progression or relapse, new treatment for lymphoma or death due to any cause and censored otherwise.; For the tisagenelcleucel ITT group: EFS was defined as the time from the date of enrollment to the date of first documented disease progression or relapse, new treatment for lymphoma or death due to any cause.
Overall Response Rate (ORR)	Up to approximately 5 years	ORR was defined as the proportion of patients with a best overall disease response of complete response (CR) or partial response (PR), respectively until progressive disease or start of new anticancer therapy, whichever came first. CR and PR efficacy evaluation was based on Cheson Response Criteria and The Lugano Classification (2014).

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States