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

Primary Purpose

Graft vs Host Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
daclizumab, infliximab
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft vs Host Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Iowa Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Treatment with daclizumab/infliximab

Outcomes

Primary Outcome Measures

Complete or partial response of GVHD to treatment according to standard staging/grading scale

Secondary Outcome Measures

incidence of chronic GVHD and overall survival

Full Information

First Posted
December 14, 2007
Last Updated
February 16, 2017
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT00574470
Brief Title
Anti Cytokine Combination Therapy With Daclizumab and Infliximab for Treatment of Steroid Refractory Acute GVHD
Official Title
Anti Cytokine Combination Therapy With Daclizumab and Infliximab for Treatment of Steroid Refractory Acute GVHD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft vs Host Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Treatment with daclizumab/infliximab
Intervention Type
Drug
Intervention Name(s)
daclizumab, infliximab
Intervention Description
Daclizumab 1 mg/kg IV days 1, 4, 8, 15 and 22. Infliximab 10 mg/kg IV days 1, 8, 15 and 22.
Primary Outcome Measure Information:
Title
Complete or partial response of GVHD to treatment according to standard staging/grading scale
Time Frame
28 days
Secondary Outcome Measure Information:
Title
incidence of chronic GVHD and overall survival
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarida Silverman, MD
Organizational Affiliation
University of Iowa Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

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

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