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NCT00726375 · ClinicalTrials.gov registry record · Phase 3
The Use of Etanercept Enbrel as Sole Treatment for Grade I Acute Graft Versus Host Disease
A Phase 3 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 34
- Enrollment target
NCT00726375 is a Phase 3 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 34 participants.
The verdict
NCT00726375, a Phase 3 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 34 participants
- Enrollment target
Study Summary
This is a clinical trial to see if treatment with etanercept for early skin graft-versus-host disease (GVHD) can effectively treat and prevent progression of the disease without using high dose steroids. GVHD is a common complication following a bone marrow transplant from another donor. GVHD occurs after transplant, when the donor's blood cells (called lymphocytes) recognize parts of your body, such as the skin, as foreign. A certain chemical, called Tumor Necrosis Factor, or TNF, also causes damage to the skin. The main effect on the skin is a red rash, when the skin GVHD is mild, but in more severe forms the skin can blister. We have been studying GVHD at the University of Michigan for the past decade. We know that high levels of TNF makes GVHD worse. Our research has shown that adding an anti-TNF drug (called etanercept or Enbrel®) to the standard GVHD treatment of high dose steroids leads to improvement in the GVHD in twice as many patients compared to when steroids alone are used. It is now standard practice at the University of Michigan and many other centers to treat GVHD with both steroids and etanercept. The management of early skin GVHD for most patients involves treatment with steroids, given both as a cream and by either the mouth (in pills) or IV. Early skin GVHD is also called grade I GVHD, which means the skin rash covers less than half of the body. Steroid treatment can be effective; however, it also causes many complications such as an increased risk of infection, weight gain, stomach ulcers, muscle weakness and bone damage, among many others. We have developed this study to test whether starting treatment with etanercept and steroid creams alone can treat the GVHD without requiring the use of high dose steroids. The goal is to avoid the complications that come with high dose oral or IV steroid treatment. The high dose steroid treatment would only begin if your GVHD got worse.
Interventions
- DRUG Etanercept (Enbrel)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2008-05 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00726375
The ClinicalTrials.gov registry entry for NCT00726375 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Etanercept (Enbrel) is the first listed.
NCT00726375 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00726375 about?
NCT00726375 is a clinical study titled "The Use of Etanercept Enbrel as Sole Treatment for Grade I Acute Graft Versus Host Disease". This is a clinical trial to see if treatment with etanercept for early skin graft-versus-host disease (GVHD) can effectively treat and prevent progression of the disease without using high dose steroids. GVHD is a common complication following a bone marrow transplant from another donor. GVHD occur...
What is the current status of trial NCT00726375?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2008-05. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00726375?
The interventions under investigation include: Etanercept (Enbrel) (DRUG).
Who is sponsoring clinical trial NCT00726375?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
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