Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of Pregnyl® when given in combination with standard immunosuppressive therapy in pediatric and adult patients with high-risk (Arm 1) or refractory/dependent (Arm 2) aGVHD.

Timeline

Start

2016-03

Primary completion

2021-05

Completion

2022-04

Publications

• Holtan SG, Hoeschen A, Cao Q, Ustun C, Betts BC, Jurdi NE, Maakaron J, Rashidi A, Miller JS, Wagner JE, Blazar BR, Jacobson PA, Panoskaltsis-Mortari A, Weisdorf DJ, MacMillan ML. Phase II, Open-Label Clinical Trial of Urinary-Derived Human Chorionic Gonadotropin/Epidermal Growth Factor for Life-Threatening Acute Graft-versus-Host Disease. Transplant Cell Ther. 2023 Aug;29(8):509.e1-509.e8. doi: 10.1016/j.jtct.2023.05.021. Epub 2023 Jun 4.
• Holtan SG, Hoeschen AL, Cao Q, Arora M, Bachanova V, Brunstein CG, Miller JS, Rashidi A, Slungaard A, Ustun C, Vercellotti GM, Warlick ED, Betts BC, El Jurdi N, He F, Chen C, Gandhi I, Wagner JE, Blazar BR, Jacobson PA, Shabaneh A, Wang J, Panoskaltsis-Mortari A, MacMillan ML, Weisdorf DJ. Facilitating resolution of life-threatening acute GVHD with human chorionic gonadotropin and epidermal growth factor. Blood Adv. 2020 Apr 14;4(7):1284-1295. doi: 10.1182/bloodadvances.2019001259.

Drugs

Indications