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

Stopped early · Phase 1/Phase 2

Conditions studied: Acute GvHD

In brief

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.

Key facts

Study ID

NCT01530256

Run by

CSL Behring

People needed

3

Starts

2012-03-01

Expected to finish

2013-03-01

Last updated by the study team

2021-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope — Duarte, California, United States
• Loyola Medical Center — Maywood, Illinois, United States
• Washington University — St Louis, Missouri, United States
• The Ohio State University — Columbus, Ohio, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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