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

NCT00574470 | Completed Phase 4 DMC

• 1 other identifier: 200511718
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft vs Host Disease

Outcome Measures

Primary Outcomes (1)

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

  28 days

Secondary Outcomes (1)

• incidence of chronic GVHD and overall survival

  9 months

Study Arms (1)

1

EXPERIMENTAL

Treatment with daclizumab/infliximab

Drug: daclizumab, infliximab

Interventions

daclizumab, infliximab DRUG

Daclizumab 1 mg/kg IV days 1, 4, 8, 15 and 22. Infliximab 10 mg/kg IV days 1, 8, 15 and 22.

1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Daclizumab; Infliximab

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

Study Officials

• Margarida Silverman, MD

  University of Iowa Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 17, 2007
• Study Start: January 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: August 1, 2008
• Last Updated: February 20, 2017

Record last verified: 2017-02

Locations

US (1)