The aim of the project is to collect and evaluate data from real clinical practice, which are related to the administration of CAR-T cell therapy in patients with certain hematological malignancies who face poor prognosis. CAR-T cell therapy is currently indicated in adult patients with certain types of non-Hodgkin's lymphoma, incl. aggressive, relapsing or refractory diffuse large B-cell lymphoma, primary mediastinal B-lymphoma, high-grade B-lymphoma, transformed follicular lymphoma and mantle cell lymphoma; and in pediatric patients and patients under 25 years of age with acute lymphoblastic leukemia (B-ALL) who do not respond to a defined number of standard therapy lines.

Project objectives

The aim of the CARTooL project is to maintain a representative database with valuable scientific and clinical data, which will contribute to improving awareness of the results of CAR-T cell therapy and, subsequently, to closer cooperation between the centers within the said treatment. Analyzes of basic clinical and safety data can provide the basis for a regular discussion within the Czech Hematological Society on the course, effectiveness and safety of this therapeutic approach in indicated hemato-oncological diseases. Data collection is not only focused on data related to the administration of CAR-T therapy and the subsequent evaluation of treatment response or treatment toxicity, but the effort is to capture the patient's overall treatment development from diagnosis to CAR-T administration, including basic evaluation of efficacy of established treatment regimens. . The registry will also monitor the patient's condition after CAR-T therapy.

Primary objectives

  • Evaluation of the effectiveness of CAR-T cell therapy based on treatment response (ORR, CR) and patient survival (OS, PFS).
  • Evaluation of the incidence and severity of side effects of CAR-T cell therapy.
  • Assessment of the effect of previous treatment, comorbidities and disease status on the parameters evaluated in objectives 1 and 2.
  • Monitoring CAR-T expansion and persistence in the patient's peripheral blood and evaluating the association with response and toxicity.
  • Monitoring of selected cytokines after CAR-T administration and evaluation of the association with toxicity.

Secondary objectives

Monitoring the number of treated patients for an overview of the current situation and discussion with health care payers. Evaluation of the risk-benefit balance in assessing the indication and for optimizing the process of selecting patients for treatment with CAR-T cell therapy.

Expert guarantors

The guarantor of the register is MUDr. Frantisek Folber, Ph.D. (University Hospital Brno Department of Internal Hematology and Oncology).

Project management is provided by the Institute of Biostatistics and Analyzes, s.r.o., a spin-off company of Masaryk University.

Michal Jetelina, Project Manager

Petr Brabec, Executive Officer