Minneapolis, Minnesota 55455


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.


Inclusion Criteria: - Acute graft versus host disease (GVHD) fitting one of the following categories: - High-Risk aGVHD (ARM 1): Pediatric or adult (ages 12-76 years) HCT recipients with high-risk acute GVHD, as determined by the refined MN acute GVHD risk score: http://z.umn.edu/MNAcuteGVHDRiskScore. Patients in this arm must start treatment within the first 7 days after onset of high-risk aGVHD. or - Steroid-Refractory aGVHD (ARM 2): Pediatric or adult (ages 12-76 years) HCT recipient with grade II-IV steroid refractory or steroid-dependent acute GVHD, defined as any one of the following: - No response of acute GVHD after at least 4 days of systemic corticosteroids of at least 2 mg/kg prednisone or equivalent - Progression of acute GVHD within 3 days of systemic corticosteroids of at least 2 mg/kg prednisone or equivalent - Failure to improve to at least grade II acute GVHD after 14 days of systemic corticosteroids, with initial doses of at least 2 mg/kg prednisone or equivalent - Flare of acute GVHD of at least grade II/IV severity despite tapering dose of steroids being > 0.5 mg/kg/day. - Adequate organ function at study enrollment defined as: - Renal: 1.73m2Serum 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 12 through 17 year olds) Exclusion Criteria: - Progressive malignancy - Diagnosis of a hormone responsive malignancy - Uncontrolled infection at initiation of protocol treatment - Current thromboembolic disease requiring full-dose anticoagulation - patients receiving pharmacologic prophylaxis for thromboembolic disease will be eligible - Active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status - Pregnancy as assessed on baseline blood hCG level - Unwilling or unable to stop supplemental sex hormone therapy (estrogen, progesterone, and/or testosterone preparations) - Women or men of childbearing potential unwilling to take adequate precautions to avoid pregnancy from the start of protocol treatment through 28 days after the last treatment



Primary Contact:

Principal Investigator
Shernan Holtan, MD
University of Minnesota - Clinical and Translational Science Institute

Timothy Krepski
Phone: 612-273-2800
Email: tkrepsk1@fairview.org

Backup Contact:


Location Contact:

Minneapolis, Minnesota 55455
United States

Tim Krepski
Phone: 612-273-2800
Email: tkrepsk1@fairview.org

Site Status: Recruiting

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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