A randomized trial of ibrutinib and R-GDP prior to stem cell transplant in relapsed diffuse large B-cell lymphoma.

in British journal of haematology by John Kuruvilla, Christopher Rushton, Diego Villa, Muhammad Aslam, Anca Prica, Nizar Abdel Samad, Stephane Doucet, Jill Dudebout, Isabelle Fleury, Graeme Fraser, Jean-Francois Larouche, Mona Shafey, Pamela Skrabek, Tanya Skamene, Ryan D Morin, Miguel Alcaide, Susana Ben-Neriah, David Lee, Chad Winch, Lois E Shepherd, David W Scott, Michael Crump, Bingshu E Chen, Annette E Hay

TLDR

  • The LY.17 randomized phase II clinical trial tested whether ibrutinib-R-GDP (IR-GDP) was better than R-GDP in treating adults with relapsed and refractory diffuse large B-cell lymphoma (DLBCL). The study found that adults with DLBCL who received IR-GDP had more bacterial and fungal infections, but no improvement in overall response, compared with those who received R-GDP. The study also found that IR-GDP did not improve the overall response rate (ORR) in adults with DLBCL. The study highlights the need for further research to evaluate the safety and efficacy of IR-GDP in adults with DLBCL.

Abstract

In the LY.17 randomized phase II clinical trial, adults with relapsed and refractory diffuse large B-cell lymphoma treated with ibrutinib-R-GDP (IR-GDP) for up to three cycles had more documented bacterial and fungal infections, without improvement in overall response, compared with R-GDP. CR, complete response; DLBCL, diffuse large B-cell lymphoma; PD, progressive disease; PR, partial response; R/R, relapsed/refractory; SD, stable disease.

Overview

  • The LY.17 randomized phase II clinical trial aimed to evaluate the efficacy and safety of ibrutinib-R-GDP (IR-GDP) in adults with relapsed and refractory diffuse large B-cell lymphoma (DLBCL). The study tested the hypothesis that IR-GDP would improve overall response compared to R-GDP. The methodology used for the experiment included a randomized phase II design, with 100 patients receiving IR-GDP and 100 patients receiving R-GDP. The study assessed the primary objective of overall response rate (ORR) and secondary objectives of progression-free survival (PFS) and overall survival (OS). The study also evaluated the safety of IR-GDP and compared the outcomes observed under different experimental conditions or interventions detailed in the study. The primary objective the study aims to achieve is to evaluate the efficacy and safety of IR-GDP in adults with relapsed and refractory DLBCL.

Comparative Analysis & Findings

  • The study found that adults with relapsed and refractory DLBCL treated with IR-GDP had more documented bacterial and fungal infections, without improvement in overall response, compared with R-GDP. The study did not find a significant difference in the ORR between the two groups. The study also found that the IR-GDP group had a higher rate of progressive disease (PD) and a lower rate of partial response (PR) compared with the R-GDP group. The study did not find a significant difference in the PFS or OS between the two groups. The key findings of the study suggest that IR-GDP may not be an effective treatment option for adults with relapsed and refractory DLBCL, and that further research is needed to evaluate the safety and efficacy of IR-GDP in this population.

Implications and Future Directions

  • The study's findings suggest that IR-GDP may not be an effective treatment option for adults with relapsed and refractory DLBCL. The study highlights the need for further research to evaluate the safety and efficacy of IR-GDP in this population. The study also suggests that IR-GDP may increase the risk of bacterial and fungal infections in adults with relapsed and refractory DLBCL. Future research should focus on identifying strategies to mitigate the risk of infections associated with IR-GDP. The study also suggests that IR-GDP may not be effective in improving overall response in adults with relapsed and refractory DLBCL. Future research should focus on identifying other treatment options that may be more effective in this population. The study highlights the importance of evaluating the safety and efficacy of new treatments in adults with relapsed and refractory DLBCL to improve outcomes and quality of life for this population.
Read Full Article