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

Inclusion Criteria:

HCT recipients over 12 years of age within the first 7 days of initial treatment of high-risk aGVHD, defined as:

• Newly diagnosed Minnesota high-risk aGVHD -OR-

• Newly diagnosed Minnesota standard risk aGVHD with plasma amphiregulin ≥ 33 pg/mltested at the UMN Cytokine Reference Lab. For amphiregulin lab ordering information,see Fairview Lab Guide:http://labguide.fairview.org/showtest.asp?testid=6766&format=long -OR-

• Newly diagnosed Minnesota standard risk aGVHD Ann Arbor 3 biomarkers tested byViracor. For ordering information, see:https://www.viracor-eurofins.com/test-menu/403572p-agvhd-symptomatic-onset-algorithm/

• Renal: Serum creatinine ≤2.5x upper limit of normal (ULN)

• Cardiac: Left ventricular ejection fraction (LVEF) ≥ 35%

• Voluntary written consent (adult or parent/guardian with minor assent for 12through 17-year-olds).

Exclusion Criteria:

• Progressive malignancy

• Uncontrolled bacterial, fungal, parasitic, or viral infection at initiation ofprotocol treatment

• Unwilling or unable to stop supplemental sex hormone therapy (estrogen,progesterone, and/or testosterone preparations)

• Unwilling or unable to stop GnRH antagonists, aromatase inhibitors, oranti-androgens

• History of a hormone responsive malignancy

• Current thromboembolic disease requiring full-dose anticoagulation - patientsreceiving pharmacologic prophylaxis for thromboembolic disease will be eligible

• Active or recent (within prior 3 months) thrombus, irrespective of anticoagulationstatus

• Pregnancy

• Women or men of childbearing potential unwilling to take adequate precautions toavoid unintended pregnancy from the start of protocol treatment through 30 daysafter the last treatment