Minneapolis, Minnesota 55455


Purpose:

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.


Criteria:

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


NCT ID:

NCT02525029


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:

N/A


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: November 22, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.