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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00053976

Public ClinicalTrials.gov record NCT00053976. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 10:01 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00053976
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
105 participants

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2000
Primary completion
Oct 31, 2003
Completion
Oct 31, 2004
Last update posted
Jan 22, 2017

2001 – 2004

United States locations

U.S. sites
8
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
Massachusetts General Hospital Boston Massachusetts 02114-2698
Brigham and Women's Hospital Boston Massachusetts 02115
Dana Farber Cancer Institute Boston Massachusetts 02115
University of Minnesota Cancer Center Minneapolis Minnesota 55455
Roswell Park Cancer Institute Buffalo New York 14263-0001
Memorial Sloan-Kettering Cancer Center New York New York 10021
Cancer Institute at Oregon Health and Science University Portland Oregon 97239-3098
Baylor University Medical Center Dallas Texas 75246

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00053976, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 22, 2017 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00053976 live on ClinicalTrials.gov.

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