NCT05123040 — drugset

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.

Timeline

Start: 2023-06-05
Primary completion: 2026-02-27
Completion: 2026-02-27

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylprednisolone	Other / unclassified	0 mg/kg	Intravenous
Subject	Methylprednisolone	Other / unclassified	0.1 mg/kg	Intravenous
Subject	Methylprednisolone	Other / unclassified	0.25 mg/kg	Intravenous
Subject	Methylprednisolone	Other / unclassified	0.5 mg/kg	Intravenous
Subject	Methylprednisolone	Other / unclassified	1 mg/kg	Intravenous
Subject	Methylprednisolone	Other / unclassified	1.5 mg/kg	Intravenous
Subject	Methylprednisolone	Other / unclassified	2 mg/kg	Intravenous
Subject	Prednisone	Other / unclassified	0 mg/kg	—
Subject	Prednisone	Other / unclassified	0.1 mg/kg	—
Subject	Prednisone	Other / unclassified	0.25 mg/kg	—
Subject	Prednisone	Other / unclassified	0.5 mg/kg	—
Subject	Prednisone	Other / unclassified	1 mg/kg	—
Subject	Prednisone	Other / unclassified	1.5 mg/kg	—
Subject	Prednisone	Other / unclassified	2 mg/kg	—
Subject	Ruxolitinib	Small molecule	10 mg	Oral
Subject	human chorionic gonadotropin	Protein / enzyme biologic	2000 unknown	Subcutaneous

Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids

Summary

Timeline

Drugs

Indications