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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00053976
First Posted: February 6, 2003
Last Update Posted: January 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Vincent T. Ho, MD, Dana-Farber Cancer Institute
February 5, 2003
February 6, 2003
January 23, 2017
January 2001
November 2003   (Final data collection date for primary outcome measure)
Rate of decrease of acute GVHD grade [ Time Frame: Day 42 ]
Not Provided
Complete list of historical versions of study NCT00053976 on ClinicalTrials.gov Archive Site
  • 100 Day Mortality [ Time Frame: 100 Day ]
  • Complete Response of GVHD [ Time Frame: 100 Days ]
  • Total Days of Antibiotic or Antifungal [ Time Frame: 100 Days ]
  • Number of Hospitalized Days [ Time Frame: 100 Days ]
  • Total Steroid Dose [ Time Frame: 100 Days ]
  • Number of Participants with Steroid related Complication [ Time Frame: 1 Year ]
  • Overall Survival [ Time Frame: 100 Days ]
  • Relapse Rate [ Time Frame: 1 Years ]
Not Provided
Not Provided
Not Provided
 
Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease
Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo

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.

GVHD occurs when the donor's immune system recognizes a patient's body as foreign and reacts against it. GVHD may result in skin rashes and blistering, liver inflammation and gastrointestinal problems including nausea, vomiting, diarrhea and bleeding. Mild GVHD may be treated with topical medications applied to the skin. More severe GVHD requires medications given intravenously (by vein) or taken by mouth. Steroids are usually given first to treat GVHD but only 40% of people respond to this alone.

OBJECTIVES:

  • 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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Graft Versus Host Disease
  • Biological: Daclizumab
    Other Name: Zenapax
  • Drug: methylprednisolone
  • Drug: Placebo
  • Experimental: Daclizumab

    Patients are randomized to 1 of 2 treatment arms.

    Arm I:

    • Patients receive methylprednisolone or equivalent corticosteroid IV or orally
    • Daclizumab IV 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.

    Interventions:
    • Biological: Daclizumab
    • Drug: methylprednisolone
  • Placebo Comparator: Placebo

    Patients are randomized to 1 of 2 treatment arms.

    • Patients receive methylprednisolone or equivalent corticosteroid as in Daclizumab arm
    • Placebo IV on days 0, 3, 7, 14, and then weekly as indicated until day 100.
    Interventions:
    • Drug: methylprednisolone
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
November 2004
November 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria

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

Exclusion Criteria

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00053976
99-279
P30CA016056 ( U.S. NIH Grant/Contract )
P30CA006516 ( U.S. NIH Grant/Contract )
RPCI-DS-0218
ROCHE-RPCI-DS-0218
Yes
Not Provided
Plan to Share IPD: No
Vincent T. Ho, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Stephanie J. Lee, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP