RATIONAL

Project title: A phase II efficacy and safety study of cell-free circulating tumor DNA-guided commencement of second-line treatment in patients with DLBCL/HGBCL relapse.

Project data

Project financing: 15 372 570 PLN ((including financing for UMED: 1 346 082,20 PLN), financed by the Medical Research Agency (ABM) - ABM/2020/1

Project description:

The aim of the RATIONAL clinical trial is to assess whether, by using a new diagnostic algorithm, it will be possible to identify DLBCL lymphoma recurrence earlier in a patients who have achieved complete remission after first-line treatment and whether earlier initiation of second-line treatment, based on this algorithm, will be more effective and safe. This algorithm is based on additional, precise monitoring in the patient’s blood of tumour biomarkers, i.e. the concentration of circulating free tumour DNA (cfDNA) in the blood. The hypothesis is that faster identification of lymphoma relapses will enable faster application of second-line treatment to the patient, which may translate into an increased chance of achieving remission and a better response to treatment.

Diffuse large B-cell lymphomas (DLBCL, Diffuse large B-cell lymphoma) are the most common non-Hodgkin’s lymphomas. They are clinically, morphologically and genetically highly heterogeneous lymphoid neoplasms derived from mature B cells at different stages of terminal differentiation. Contemporary first-line treatment achieves remission in approximately 60% of DLBCL patients, of whom approximately 40% relapse. Monitoring of patients after first-line treatment is based on clinical and radiological assessment. Such management does not allow early features of disease recurrence to be captured, so that the timing of starting second-line treatment occurs with a relatively large tumour mass. Early identification of refractory patients and early identification of relapses are therefore extremely important challenges in the current therapeutic paradigm.

Beneficiary

Consortium composed of:

Institute of Haematology and Transfusiology (Leader)

Medical University of Lodz (Partner)

Polish Lymphoma Research Group (Plrg) (Partner)

Coordinating Principal Investigator

Prof. dr hab.n. med. Ewa Lech-Marańda, MD, PhD

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