Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids
Status:
Not yet recruiting
Trial end date:
2028-09-01
Target enrollment:
Participant gender:
Summary
This multi-center center phase I/II study to establish the lowest possible recommended phase
2 dose (RP2D) of corticosteroids in conjunction with ruxolitinib and uhCG/EGF (a novel
combination) for high-risk aGVHD.
This is a single arm study designed to determine the lowest dose of corticosteroids required
(toxicity endpoint) without impairing GVHD complete response or partial response (CR/PR) at
day 28 when given in conjunction with uhCG/EGF and ruxolitinib.
After completion of the corticosteroid dose finding, the final dose will be carried forward
into a two-stage phase II extension trial to confirm safety and make a preliminary
determination of efficacy of this novel drug combination for high-risk aGVHD.