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. 2023 Oct 6;84(1):101–117. doi: 10.1158/0008-5472.CAN-23-1992

Figure 4.

Figure 4. Selinexor in combination with R-ICE in patients with aggressive B-cell lymphomas. A, Flowchart of clinical trial design with allocation results and number of DLT events. Twenty-two subjects were enrolled (19 in standard aggressive B-cell lymphoma cohort and three in RT cohort). DLBCL-NOS, DLBCL not otherwise specified; PMBL, primary mediastinal B-cell lymphoma. B, Dosing schedule with patient allocation and DLT for the 19 subjects enrolled in the DLBCL cohort. From the three RT subjects, one subject was taken off the trial prior to receiving selinexor because of neurotoxicity due to ifosfamide and the other two subjects did not experience a DLT. In the initial dosing schedule (n = 3) at 60 mg there were no DLTs. Two DLTs were observed when dose subsequently increased to 80 mg, prompting de-escalation to 60 mg and enrolling three additional subjects at that dose level. One of the second group of three subjects experienced grade 3 AMS. At that point, the protocol was modified so that the selinexor was dosed after completion of ifosfamide. C, Waterfall plot of best relative percent change from baseline in tumor size for 18 patients. Of 20 subjects evaluable for response, one progressed prior to imaging response assessment and one with complete response on PET had no measurable disease, and thus, is not included in the waterfall plot. Solid columns, modified schedule; dashed columns, initial schedule.

Selinexor in combination with R-ICE in patients with aggressive B-cell lymphomas. A, Flowchart of clinical trial design with allocation results and number of DLT events. Twenty-two subjects were enrolled (19 in standard aggressive B-cell lymphoma cohort and three in RT cohort). DLBCL-NOS, DLBCL not otherwise specified; PMBL, primary mediastinal B-cell lymphoma. B, Dosing schedule with patient allocation and DLT for the 19 subjects enrolled in the DLBCL cohort. From the three RT subjects, one subject was taken off the trial prior to receiving selinexor because of neurotoxicity due to ifosfamide and the other two subjects did not experience a DLT. In the initial dosing schedule (n = 3) at 60 mg there were no DLTs. Two DLTs were observed when dose subsequently increased to 80 mg, prompting de-escalation to 60 mg and enrolling three additional subjects at that dose level. One of the second group of three subjects experienced grade 3 AMS. At that point, the protocol was modified so that the selinexor was dosed after completion of ifosfamide. C, Waterfall plot of best relative percent change from baseline in tumor size for 18 patients. Of 20 subjects evaluable for response, one progressed prior to imaging response assessment and one with complete response on PET had no measurable disease, and thus, is not included in the waterfall plot. Solid columns, modified schedule; dashed columns, initial schedule.