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

NCT00053976 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2017-01-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Daclizumab

DRUG

methylprednisolone

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Stephanie J. Lee, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2003-11-30
Completion
2004-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00053976 on ClinicalTrials.gov