Anti Cytokine Combination Therapy With Daclizumab and Infliximab for Treatment of Steroid Refractory Acute GVHD - Full Text View

Sponsored by:	University of Iowa
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00574470

Purpose

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.

Condition	Intervention	Phase
Graft vs Host Disease	Drug: daclizumab, infliximab	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Anti Cytokine Combination Therapy With Daclizumab and Infliximab for Treatment of Steroid Refractory Acute GVHD

Resource links provided by NLM:

Drug Information available for: Dacliximab Infliximab

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:

Complete or partial response of GVHD to treatment according to standard staging/grading scale [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

incidence of chronic GVHD and overall survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	37
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
1: Experimental 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574470

Contacts

Contact: Karen Parrott, BSN

319-353-6347

karen-parrott@uiowa.edu

Locations

United States, Iowa
University of Iowa Hospitals	Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Margarida Silverman, MD

Sponsors and Collaborators

University of Iowa

Investigators

Principal Investigator:

Margarida Silverman, MD

University of Iowa Hospitals

More Information

No publications provided

Responsible Party:	University of Iowa Hospitals & Clinics ( Margarida Silverman, MD )
Study ID Numbers:	200511718
Study First Received:	December 14, 2007
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00574470 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Inflammatory Agents
Graft Versus Host Disease
Immunologic Factors
Infliximab
Daclizumab

Graft vs Host Disease
Antirheumatic Agents
Immunosuppressive Agents
Homologous Wasting Disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immune System Diseases
Immunologic Factors
Infliximab
Daclizumab
Physiological Effects of Drugs
Gastrointestinal Agents

Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Graft vs Host Disease
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 11, 2009