Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 5, 2003
Last updated: February 6, 2009
Last verified: December 2003

RATIONALE: Daclizumab combined with methylprednisolone may be an effective treatment for acute graft-versus-host disease caused by bone marrow transplantation. It is not yet known if methylprednisolone is more effective with or without daclizumab in treating acute graft-versus-host disease.

PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with or without daclizumab in treating patients who have acute graft-versus-host disease following donor bone marrow transplantation.

Condition Intervention Phase
Graft Versus Host Disease
Biological: daclizumab
Drug: methylprednisolone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2002
Detailed Description:


  • Compare response to treatment in patients with acute graft-versus-host disease (GVHD) treated with methylprednisolone with or without daclizumab.
  • Compare differences in total methylprednisolone dose and complications in patients treated with these regimens.
  • Compare mortality, days of antibiotics and antifungal therapy, and required hospital days within the first 100 days for patients treated with these regimens.
  • Compare overall survival and incidence of chronic GVHD at 1 year in patients treated with these regimens.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to prior graft-versus-host disease (GVHD) prophylaxis (immunosuppressive therapy vs T-cell depletion), GVHD organ manifestation (skin only vs other), donor type (6/6 matched sibling vs other), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive methylprednisolone or equivalent corticosteroid IV or orally and daclizumab IV over 15 minutes on days 0, 3, 7, 14, and then weekly as indicated until day 100.
  • Arm II: Patients receive methylprednisolone or equivalent corticosteroid as in arm I and placebo.

Patients are followed at 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 166-190 patients will be accrued for this study within 2 years.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Acute graft-versus-host disease (GVHD) requiring systemic therapy

    • Grade 2 (skin GVHD)
    • Grade 2-4 (overall GVHD)
  • Received allogeneic bone marrow transplantation
  • No acute GVHD diagnosed solely by upper gastrointestinal involvement
  • No GVHD from donor lymphocyte infusion



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No mental or emotional conditions that would preclude study therapy
  • No known hypersensitivity to daclizumab


Biologic therapy

  • See Disease Characteristics
  • No prior daclizumab


  • Not specified

Endocrine therapy

  • More than 7 days since prior prophylactic or therapeutic steroids at greater than 1 mg/kg/day
  • Steroids for amphotericin premedication allowed provided dose is less than 1 mg/kg/day


  • Not specified


  • Not specified


  • More than 30 days since prior investigational therapies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00053976

United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114-2698
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Stephanie J. Lee, MD Dana-Farber Cancer Institute
  More Information Identifier: NCT00053976     History of Changes
Other Study ID Numbers: CDR0000269672  DFCI-99279  RPCI-DS-0218  ROCHE-RPCI-DS-0218 
Study First Received: February 5, 2003
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
graft versus host disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunoglobulin G
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors processed this record on January 14, 2017