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

Information source: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Graft vs Host Disease

Intervention: Pregnyl® (Drug)

Phase: Phase 1/Phase 2

Status: Not yet recruiting

Sponsored by: Masonic Cancer Center, University of Minnesota

Official(s) and/or principal investigator(s):
Shernan Holtan, MD, Principal Investigator, Affiliation: University of Minnesota - Clinical and Translational Science Institute

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

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 (Arm 2) aGVHD.

Clinical Details

Official title: Phase I/II Study of Human Chorionic Gonadotropin and Epidermal Growth Factor Supplementation (Pregnyl«) to Support Tolerance and Repair As Adjunct Therapy in High-Risk or Refractory Acute Graft-Versus-Host Disease

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome:

Phase I: MTD

Phase II: Number of Patients with Response

Phase II: Number of Patients with Response

Phase II: Number of Patients with Response

Phase II: Number of Patients with Response

Secondary outcome:

Number of Participants with Adverse Events as a Measure of Safety and Feasibility of hCG Supplementation with Pregnyl®

Number of Participants with Incidence of aGVHD Flare

Number of Participants with Incidence of aGVHD Flare

Rate of participants who fail treatment at Day 28

Rate of participants who fail treatment at Day 56

Eligibility

Minimum age: 12 Years. Maximum age: 76 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Acute graft versus host disease (GVHD) fitting one of the following categories:

1. 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 (29): http://z. umn. edu/MNAcuteGVHDRiskScore. Patients in this arm must start treatment within the first 7 days after onset of high-risk aGVHD. or 2. 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.

- Voluntary written consent (adult or parent/guardian with minor assent for 12 through

17 year olds) Exclusion Criteria:

- Progressive 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

- Pregnancy as assessed on baseline blood hCG level

- 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

Locations and Contacts

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

Additional Information

Starting date: September 2015
Last updated: August 13, 2015

Page last updated: August 23, 2015

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