{Reference Type}: Clinical Trial, Phase II
{Title}: Obinutuzumab plus bendamustine for relapsed/refractory chronic lymphocytic leukemia and predictive and prognostic impact of genetic alterations: the phase II GABRIELL study.
{Author}: Bravo J;Baltasar Tello P;González Garcia E;Ríos Herranz E;Páyer AR;Terol Castera MJ;Champ D;Medina Perez A;Gironella M;Fernández Zarzoso M;Forés R;Delgado J;Garcia-Marco JA; ;
{Journal}: Leuk Lymphoma
{Volume}: 64
{Issue}: 5
{Year}: 2023 05 31
暂无{DOI}: 10.1080/10428194.2023.2216327
{Abstract}: GABRIELL was a phase II single-arm study to evaluate the efficacy and safety of obinutuzumab plus bendamustine for relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Seventy-two patients with active disease received treatment for up to six 28-day cycles. Overall response rate was 78.6% with a median progression-free survival (PFS) of 26 months, and overall survival (OS) not reached at the end of follow-up (36 months). Undetectable measurable residual disease (≤0.01%; 36.4% in bone marrow and 53.4% in peripheral blood) correlated with a significantly longer PFS and OS (vs. >0.01). Common grade ≥3 adverse events (76.4%) were neutropenia (58.3%), thrombocytopenia (26.4%) and febrile neutropenia (11.1%). TP53 disruption was the only independent predictive factor for response (Hazard ratio; HR: 0.228). Unmutated immunoglobulin heavy chain variable region (HR: 16.061) was a negative prognostic factor for PFS. In conclusion, the combination of obinutuzumab plus bendamustine is an active and generally adequately-tolerated treatment for R/R CLL.