Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Graft Versus Host Disease

In brief

The purpose of this study is to compare the effects of IL2 receptor antibody (also known as Daclizumab or Zenapax) and corticosteroids alone for control of GVHD. Treatment with corticosteroids is standard care for GVHD. This research is being done because the investigators do not know whether addition of this new medication to standard corticosteroid therapy improves response rates. Since Zenapax binds to a type of cell which is thought to cause GVHD and possibly inactivates them, investigators have reason to believe that addition of Zenapax night result in better control of GVHD This study will determine whether the addition of another medication, Zenapax, will be more effective than steroids alone in suppressing GVHD and improving symptoms of GVHD. Daclizumab (Zenapax) is approved by the Food and Drug Administration (FDA) for use in patient with kidney transplant to help prevent graft rejection. This medication has been used in bone marrow transplant patients to treat GVHD.

Key facts

Study ID

NCT00053976

Run by

Dana-Farber Cancer Institute

People needed

105

Starts

2001-01-01

Expected to finish

2004-11-01

Last updated by the study team

2017-01-23

Who can join

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

You may qualify if…

• Allogeneic Transplantation
• Acute GVHD requiring therapy (skin stage 2 or overall grade II-IV)
• Signed, informed consent

You may not qualify if…

• Mental or emotional contraindications as determined by patient's physician
• Steroids given prophylactically or therapeutically at a dose > 1 mg/kg/d methylprednisolone (including prevention of acute GVHD or treatment for diffuse alveolar hemorrhage and severe obstructive mucositis within 7 days prior to starting acute GVHD therapy. Steroids administered as amphotericin premedication are allowed if below 1 mg/kg/day.
• Acute GVHD diagnosed solely by virtue of upper GI GVHD
• Hypersensitivity to Daclizumab or prior therapy with Daclizumab
• GVHD from donor lymphocyte infusion
• Other investigational therapeutics within 30 days of enrollment
• Pregnancy or of fertile, failure to agree to use contraception

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Minnesota Cancer Center — Minneapolis, Minnesota, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Cancer Institute at Oregon Health and Science University — Portland, Oregon, United States
• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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