Anti Cytokine Combination Therapy With Daclizumab and Inf... | NCT00574470

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

NCT00574470

Sponsor

University of Iowa

Status

Completed

Last Update Posted

Feb 20, 2017Actual

Enrollment

3Actual

Phase

Phase 4

Conditions

Graft vs Host Disease

Interventions

daclizumab, infliximab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Nov 2007Actual

Completion Date

Aug 2008Actual

First Submitted Date

Dec 14, 2007

First Submission Date that Met QC Criteria

Dec 14, 2007

First Posted Date

Dec 17, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2017

Last Update Posted Date

Feb 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Label	Type	Description	Intervention Names
1	Experimental	Treatment with daclizumab/infliximab	Drug: daclizumab, infliximab

Name	Type	Description	Arm Group Labels	Other Names
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

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

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins