Graft vs Host DiseasePhase 4NCT00574470
Anti Cytokine Combination Therapy With Daclizumab and Infliximab for Treatment of Steroid Refractory Acute GVHD
A Phase 4 study testing daclizumab, infliximab in people with Graft vs Host Disease, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft vs Host Disease
- What is being tested?
- daclizumab, infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Aug 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- daclizumab, infliximab
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daclizumab, infliximabDrug
Daclizumab 1 mg/kg IV days 1, 4, 8, 15 and 22. Infliximab 10 mg/kg IV days 1, 8, 15 and 22.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment with daclizumab/infliximab Receives: Drug: daclizumab, infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete or partial response of GVHD to treatment according to standard staging/grading scale
Measured: 28 days
Secondary outcomes (1)
incidence of chronic GVHD and overall survival
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startJan 2006
- Primary completionNov 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magalhaes-Silverman, Margarida, University of Iowa
- Investigators
- Margarida Silverman, MD, Principal investigator, University of Iowa Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574470
- Sponsor's protocol ID
- 200511718
- Status last verified
- Feb 2017
- First submitted
- 14 Dec 2007
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti Cytokine Combination Therapy With Daclizumab and Infliximab for Treatment of Steroid Refractory Acute GVHD
- ClinicalTrials.gov ID
- NCT00574470
- Acronym / sponsor ID
- 200511718
- Conditions
- Graft vs Host Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: daclizumab, infliximabTreatment with daclizumab/infliximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| daclizumab, infliximabDaclizumab 1 mg/kg IV days 1, 4, 8, 15 and 22. Infliximab 10 mg/kg IV days 1, 8, 15 and 22. | Drug | 1 |
Primary outcome
Complete or partial response of GVHD to treatment according to standard staging/grading scale
Time frame: 28 days
1 secondary outcome
incidence of chronic GVHD and overall survival
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
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Graft vs Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarida Silverman, MD principal investigator
University of Iowa Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing daclizumab, infliximab in people with Graft vs Host Disease, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete or partial response of GVHD to treatment according to standard staging/grading scale (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2017.