PREV-CART - A multicentric phase III randomized clinical trial open-label, comparing immunoglobulin replacement therapy (IgRT) and antibiotic prophylaxis (AP) in patients treated by CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for a B cell acute lymphoblastic leukemia or a B cell lymphoma

Young Adults and adults with R/R B-cell acute lymphoblastic leukemia (BCP-ALL) or a B cell lymphoma (BCL)

A composite outcome defined by the occurrence of either recurrent infections (defined by at least 2 episodes requiring a curative systemic antibiotic treatment) or a severe infection (defined by the need of hospitalization) between randomization and M12.

- Cumulative hazard of severe (requiring hospitalization) infections within 12 months, - Infection-free survival rate at M12, - Occurrence of COVID19 infection within 12 months, - Cumulative incidence of readmissions due to infectious episode after hospital discharge following the infusion of CAR-T cells within 12 months, - Incidence of adverse events due to IgRT and/or PA between randomization and M12, - Measures of IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts at lymphodepletion, M1, M3, M6, M9, M12, - Quality of life measured on QLQ-C30 and EQ5D5L, - Cost effectiveness and cost utility: incremental cost effectiveness/utility ratios

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