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

NCT07103486 | Completed

• 1 other identifier: CCTL019CDE01
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

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).

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

Relapsed; Refractory

Outcome Measures

Primary Outcomes (4)

• Overall Survival (OS)

  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.

  Up to approximately 5 years

• Progression-free Survival (PFS)

  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.

  Up to approximately 5 years

• Event-free Survival (EFS)

  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.

  Up to approximately 5 years

• Overall Response Rate (ORR)

  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).

  Up to approximately 5 years

Study Arms (3)

Tisagenlecleucel Full Analysis Set (FAS) Group

Adult patients with r/r DLBCL who were enrolled in the JULIET trial and received an infusion of tisagenlecleucel.

Tisagenlecleucel Intention To Treat (ITT) Group

Adult patients with r/r DLBCL who were enrolled in the JULIET trial.

External Control Group

Adult patients with r/r DLBCL after two or more lines of chemotherapy. Patient data was collected from German medical center chart reviews.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• Aged 18 years or older.
• Histologically confirmed DLBCL, transformed indolent Non-Hodgkin Lymphoma (NHL) was also allowed (such as transformed follicular lymphoma).
• r/r DLBCL after 2 or more chemotherapy lines, including rituximab and anthracycline. Previous autologous hematopoietic stem cell transplantation (HSCT) was allowed. For transformed indolent NHL, anthracycline treatment before transformation was allowed.
• Had received patient-individual therapy in the qualifying line(s) (3rd or to a maximum of 9th line). Patient-individual therapy was chosen in consideration of molecular genetic lymphoma characteristics, previous therapies, disease history and patient's general condition, including an allogeneic HSCT where possible. Best supportive care in the palliative setting was also a treatment option.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Even if no ECOG performance status or Karnofsky Index was documented in patient charts the patient could be eligible for documentation.
• Had adequate organ function at the discretion of the treating physician:
• Adequate pulmonary reserve (e.g. ≤ Grade 1 dyspnea and pulse oxygenation \> 91 % on room air)
• Hemodynamically stable and adequate cardiac function (e.g. Left Ventricular Ejection Fraction (LVEF) ≥ 45 %)

You may not qualify if:

• Received more than 8 treatment lines before qualifying treatment failure.
• Active central nervous system (CNS) involvement by malignancy.
• Had prior allogeneic HSCT.
• Human immunodeficiency virus (HIV)-positive patients.
• Had uncontrolled, acutely life-threatening bacterial, viral or mycotic infections (e.g. blood culture positive ≤ 72 hours before treatment start).
• Had unstable angina pectoris and/or myocardial infarct within 6 months before qualifying treatment failure.
• Had previous or concurrent malignant tumor disease with some exceptions (basal cell or squamous cell carcinoma, curatively treated in-situ carcinoma of the cervix or breast, curatively treated primary malignant tumor disease in complete remission for ≥ 5 years).
• Had cardiac arrhythmias that could not be controlled with drug treatment.
• Patients with T-cell-rich/histiocyte-rich large B-cell lymphoma (THRBCL), primary cutaneous large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL), Epstein Barr virus (EBV)-positive DLBCL in the elderly, Richter's transformation, and Burkitt lymphoma.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Recurrence

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: July 29, 2025
• First Posted: August 5, 2025
• Study Start: April 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

US (1)