Low-Dose Selinexor and Choline Salicylate for the Treatment of Patients With Residual, Relapsed or Refractory Non-Hodgkin Lymphoma

Summary

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Description

PRIMARY OBJECTIVE: I. To evaluate the maximum tolerated dose (MTD) of choline salicylate (CS) that can be combined with selinexor twice weekly in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL) or mantle cell lymphoma (MCL). SECONDARY OBJECTIVE: I. To evaluate the response (o...

PRIMARY OBJECTIVE: I. To evaluate the maximum tolerated dose (MTD) of choline salicylate (CS) that can be combined with selinexor twice weekly in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL) or mantle cell lymphoma (MCL). SECONDARY OBJECTIVE: I. To evaluate the response (overall response rate [ORR], clinical benefit rate [CBR] and duration of response [DOR]) of selinexor and CS in patients with relapsed/refractory DLBCL or MCL. CORRELATIVE RESEARCH OBJECTIVE: I. To determine if CRM1 expression in malignant lymphoma cells from patients treated on this study have a predictive role. OUTLINE: This is a dose-escalation study. Patients receive selinexor orally (PO) twice a week (BIW) on days 1, 3, 8, 10, 15, 17, 22, and 24, and choline salicylate PO three times daily (TID) on days 1-28. Patients undergoing pharmacokinetic analysis receive choline salicylate beginning on day 3 of cycle 1 (D3C1) and beginning on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patents who achieve >= stable disease continue treatment for an additional 6 cycles (maximum of 12 cycles) at the discretion of the treating physician and patient.

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