Acute GvHD

Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)

NCT01530256 | PHASE 1 | INTERVENTIONAL

The purpose of this study is to determine the safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further investigation in Part B.

5 Sites

3 Participants

Recruiting

18 Years to 12 Years

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Find closest sites:

SUBMIT

City of Hope

Duarte,California,United States,91010

Loyola Medical Center

Maywood,Illinois,United States,60153

Washington University

Saint Louis,Missouri,United States,63110

The Ohio State University

Columbus,Ohio,United States,43210

Virginia Commonwealth University

Richmond,Virginia,United States,23298

Study Eligibility Criteria

Inclusion Criteria

* Glucocorticosteroid refractory acute GVHD Grade 2-4
* Prior corticosteroid therapy at \> 1.0mg/kg methylprednisolone or equivalent for minimum of 3 and maximum of 14 days
* Karnofsky Performance Satus Scale ≥ 50%
* Adequate laboratory testing at screening

Exclusion Criteria

* Subjects having Stage 1 skin acute GVHD
* Subjects with Stage 3 or 4 liver GVHD
* Prior EBV associated malignancy
* Prior or current Hepatitis B or C
* Prior or active tuberculosis

Additional Studies

Additional studies can be found at ClinicalTrials.gov