Anti Cytokine Combination Therapy With Daclizumab and Infliximab for Treatment of Steroid Refractory Acute GVHD

February 16, 2017 updated by: Magalhaes-Silverman, Margarida, University of Iowa
The purpose of this study is to see whether serious graft versus host disease which is not well controlled with steroid treatment can be controlled with therapy with both daclizumab and infliximab. We hypothesize that a combination of daclizumab and infliximab will more effectively treat graft versus host disease than therapy with a single drug. The study also looks at whether chronic graft versus host disease develops, and survival at 6 and 9 months post-treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of steroid refractory aGVHD defined as no response to methylprednisolone at 2 mg/kg for 1 week or disease progression after 72 hours of methylprednisolone at this dose. Potential subject will have had no decrease in any GVHD organ staging as follows:

    • Skin rash, if present, does not decrease by one stage. This is based on the percent of the body involved with rash, plus presence of bullae and desquamation.
    • Gut GVHD, if present, does not decrease by one stage. This is based on volume of diarrhea, pain, and ileus.
    • Upper gastrointestinal GVHD, if present, does not resolve.
    • Liver GVHD, if present, does not decrease by one stage. This is based on total bilirubin level.
  • Prior allogeneic hematopoietic stem cell transplantation using bone marrow, peripheral blood or umbilical cord cells. Recipients of standard as well as nonmyeloablative transplants are eligible.
  • No previous immune suppressive therapy given for treatment of acute GVHD except for corticosteroids.
  • Absolute neutrophil count greater than 0.5x106/L.
  • Estimated creatinine clearance greater than 30 mL/minute.
  • Written informed consent

Exclusion Criteria:

  • Patient receiving either infliximab or daclizumab within seven days of study.
  • Patient with uncontrolled infections will be excluded.
  • Patients receiving other investigational agents for GVHD prophylaxis or treatment.
  • Patients with congestive heart failure.
  • Patients with history of intolerance/ hypersensitivity to daclizumab or infliximab.
  • Age less than 18 years.
  • Patients who are pregnant or at risk of pregnancy and unwilling to use acceptable birth control methods.
  • Patients with an allergy to murine products.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Treatment with daclizumab/infliximab
Drug: daclizumab, infliximab
Daclizumab 1 mg/kg IV days 1, 4, 8, 15 and 22. Infliximab 10 mg/kg IV days 1, 8, 15 and 22.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete or partial response of GVHD to treatment according to standard staging/grading scale
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of chronic GVHD and overall survival
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Investigators

  • Principal Investigator: Margarida Silverman, MD, University of Iowa Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

December 14, 2007

First Submitted That Met QC Criteria

December 14, 2007

First Posted (Estimate)

December 17, 2007

Study Record Updates

Last Update Posted (Actual)

February 20, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200511718

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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