Page 152 - Haematologica Vol. 110 - January 2025

ARTICLE - R-GemOx+Atezo in R/R transformed DLBCL the start of the study, then every 6 months while receiving
maintenance therapy.
Study outcomes and statistical analyses
The primary endpoint was to establish safety and dosing of R-GemOx+Atezo by documenting adverse events and determining the maximum tolerated dose/RP2D. To be evaluable for DLT, a patient must have either experienced a DLT during the DLT period (i.e., cycle 2), or received the total planned doses of all drugs during the DLT period and not experienced a DLT (which included a therapy delay of >2 weeks due to a treatment-related toxicity). During the safety portion of the study, patients who were not evalu- able for DLT were replaced. A list of the full DLT criteria can be found in the Online Supplementary Appendix. Toxicity monitoring was continued beyond the 28-day DLT period because of the immune-related adverse events associat- ed with checkpoint inhibitors. Secondary endpoints were overall response rate, complete response rate, duration of response, progression-free survival, and overall survival. Baseline characteristics were summarized using descriptive statistics. Responses were determined using the Lugano
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T. Othman et al.
2014 criteria.27 Duration of response was calculated from the time of first documented response to progression or death. Progression-free survival was calculated as the time from start of treatment to the date of progression or death, whichever came first. Overall survival was calculated as the time from start of treatment until death. Patients who were alive and free of progression were censored at the date of last follow-up. Patients who started another therapy prior to progression were censored at that time. Survival estimates were calculated using the Kaplan-Meier method.
Results
Participants’ characteristics
Twenty-seven patients were enrolled and received treat- ment (Figure 1B). All patients were evaluable for efficacy and safety. The patients’ baseline characteristics are listed in Table 1. The median age was 68 years (range, 44-80), 14 patients (52%) had transformed FL, while 13 patients (48%) had transformed non-FL (9 chronic lymphocytic leukemia/
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Figure 1. Clinical trial profile of this sin- gle-arm trial of rituximab, gemcitabine, oxaliplatin, and atezolizumab. (A) Study schema. (B) CONSORT diagram. EOT: end of treatment; DLT: dose-limiting toxicity; PET/CT: positron emission tomography/ computed tomography; PB: peripheral blood; BX: biopsy; C8D1: cycle 8, day 1.