NCT05123040 - Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 5, 2023

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2028

Conditions

Acute-graft-versus-host Disease

Interventions

DRUG

Ruxolitinib 10 MG Oral Tablet

By mouth twice daily through day 56, then tapered

DRUG

hCG

2,000 units/m2 SQ every other day x 3 doses, followed by twice weekly x 14 doses

DRUG

Corticosteroids

"Dose level 1 (starting dose) = 1 mg/kg~* Dose level 2 = 0.5 mg/kg~* Dose level 3 = 0.25 mg/kg~* Dose level 4 = 0.1 mg/kg~* Dose level 5 = 0 mg/kg~ • If dose level 1 is determined to be below the Recommended Phase 2 Dose (RP2D), the dose will be escalated:~* Dose level -1 = 1.5 mg/kg~* Dose level -2 = 2 mg/kg"

Trial Locations (1)

55455

RECRUITING

Masonic Cancer Center at University of Minnesota, Minneapolis

All Listed Sponsors

lead

Masonic Cancer Center, University of Minnesota

OTHER