A recently proposed trial aims to determine the benefits of monoclonal antibodies in patients with refractory or relapsed diffuse large B cell lymphoma (DLBCL) that had previously undergone a chemotherapy scheme along with chimeric antigen receptor (CAR) T cell therapy.

This interventional study in initiating phase II of a randomized clinical trial with a parallel assignment. All patients will receive chemotherapy with fludarabine combined with cyclophsphamide and a CAR T cell therapy with either axicabtagene cioleucel, lisocabtagene maraleucel, or tisagenlecleucel. Then, a group of patients will receive mosunetuzumab, another group will have polatuzumab vedotin, and a third group will receive both drugs.

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This trial will include a total of 396 participants, who were at least 18 years of age, of both sexes, previously diagnosed with DLBCL or follicular lymphoma grade 3b, or primary mediastinal large B cell lymphoma.

The researchers will monitor and follow all participants while also collecting positron emission tomography (PET-CT), computerized tomography (CT), and blood and tissue sample analysis as required to compare such variables among the different groups later. Moreover, patients that showcase disease progression at the 12 month follow-up, will be reassigned to the combined mosunetuzumab and polatuzumab vedotin group.

The primary outcome is the progression-free survival from the date of randomization to a check-up 2 years later of each group and the comparison among them.

As for the secondary outcomes, the study will determine the overall survival, complete remission conversion rate, incidence of adverse events, the association between total metabolic tumor volume, standardized uptake value max, and sum product of diameters, as assessed by the PET-CT, and finally, the conversion to complete response.

Individuals under 18 years old, without the 3 neoplastic conditions, with symptomatic central nervous system disease, or that do not qualify for receiving CAR T cell therapy can not participate.

This clinical trial is yet to recruit and could potentially start in December of the current year and end in December 2029.

Reference

Testing drug treatments after car T-cell therapy in patients with relapsed/refractory diffuse large B-cell lymphoma. ClinicalTrials.gov. December 5, 2022. Accessed December 14, 2022.