Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD
Status:
Recruiting
Trial end date:
2025-10-01
Target enrollment:
Participant gender:
Summary
An open-label, Phase II trial designed to assess the recommended phase 2 dose (RP2D) of
itacitinib in combination ECP and efficacy of the combination after 24 weeks of therapy. The
trial will consist of two parts: Part One will assess the RP2D. For dose-finding purposes,
the DLT evaluation period will be defined as the time from the first dose of itacitinib
lead-in (7-day lead-in) to the last day of cycle one combination therapy (Cycle one day 28).
Part Two will further describe and characterize the safety and efficacy of the regimen. The
RP2D will be determined by a 3+3 dose de-escalation design. Should dose level one be deemed
intolerable, enrollment will proceed at dose level -1. The RP2D will be affirmed according to
the rules of the 3+3 dose de-escalation scheme (Section 4.2). Once an RP2D has been
confirmed, Part 2 will open as an expansion cohort.