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

Novartis

Status

Completed

Conditions

Diffuse Large B-Cell Lymphoma

Study type

Observational

Funder types

Industry

Identifiers

NCT07103486

CCTL019CDE01

Details and patient eligibility

About

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).

Enrollment

264 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 %)

Exclusion criteria

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.