TEMPO: A Phase 2, Randomized, Open-Label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects with Indolent Non Hodgkin Lymphoma (iNHL)

Blood(2021)

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摘要
Dosing with duvelisib 25 mg BID has been shown to be efficacious in iNHL, most notably the pivotal phase 2 DYNAMO study (NCT01882803) in follicular lymphoma (FL). The TEMPO study (NCT04038359) was designed to examine the effects of prespecified 2-week dose holidays on tumor responses and safety/tolerability in patients with iNHL (FL, MZL), based on data from a phase 3 trial (DUO) in CLL/SLL which demonstrated no negative impacts of (unscheduled) dose interruptions on response.
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