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

NCT00053976 | Completed Phase 3 DMC

• 5 other identifiers: 99-279P30CA016056P30CA006516RPCI-DS-0218ROCHE-RPCI-DS-0218
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 8

Brief 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

Graft Versus Host Disease

Keywords

graft versus host disease

Outcome Measures

Primary Outcomes (1)

• Rate of decrease of acute GVHD grade

  Day 42

Secondary Outcomes (8)

• 100 Day Mortality

  100 Day

• Complete Response of GVHD

  100 Days

• Total Days of Antibiotic or Antifungal

  100 Days

• Number of Hospitalized Days

  100 Days

• Total Steroid Dose

  100 Days

Study Arms (2)

Daclizumab

EXPERIMENTAL

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.

Biological: Daclizumab; Drug: methylprednisolone

Placebo

PLACEBO COMPARATOR

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.

Drug: methylprednisolone; Drug: Placebo

Interventions

Daclizumab BIOLOGICAL

Also known as: Zenapax

Daclizumab

methylprednisolone DRUG

Daclizumab; Placebo

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

Massachusetts General Hospital

Boston, Massachusetts, 02114-2698, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Daclizumab; Methylprednisolone

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Stephanie J. Lee, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VIncent T. Ho, MD

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: January 1, 2001
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2004
• Last Updated: January 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)