Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00726375
Other study ID # UMCC 2007.139
Secondary ID HUM 17897
Status Completed
Phase Phase 3
First received July 28, 2008
Last updated December 4, 2015
Start date May 2008
Est. completion date September 2014

Study information

Verified date December 2015
Source University of Michigan Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date September 2014
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

1. Patient must have undergone HCT (donor cells from any source) with either a myeloablative or nonmyeloablative preparative regimen.

2. Patient may be any age.

3. Patient must have biopsy-proven Grade I acute GVHD (Appendix A). Biopsy report does not have to be back from Pathology prior to enrollment. Patients whose biopsy for GVHD identifies pathology inconsistent with GVHD will be removed from the study and replaced. However, because GVHD is a clinical diagnosis, biopsies which are non-diagnostic or do not show a clear non-GVHD etiology will not be cause to remove the patient from the study.

Exclusion Criteria:

1. Patients who are pregnant (positive urine or serum test) or nursing.

2. Active infections which are unresponsive to antibiotics (> 2 consecutive [at least 24 hours apart], positive blood cultures after initiation of treatment).

3. Allergic or otherwise undesirable reaction to etanercept.

4. Use of any oral or intravenous steroids at any previous time for GVHD treatment. Prior use of steroid therapy (i.e. hydrocortisone) as pre-medication for transfusions is permissible. Prior use of topical steroids is allowed.

5. Use of etanercept for any other purpose.

6. Noncompliance with medications.

7. Grade II-IV GVHD (history of or at time of study entry).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Etanercept (Enbrel)
Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Percentage of Patients Who Progress Within 28 Days of Initiation of Etanercept Treatment We hypothesized that treatment of grade 1 acute GVHD (Graft Versus Host Disease) with etanercept would reduce the proportion of patients who progressed to grade 2 to 4 acute GVHD within 4 weeks of diagnosis from 58%, historically observed at our institution, to 38%. 28 days Yes
Secondary The Number of Patients in Complete Remission (CR) at Four Weeks. Estimate the proportion of patients in complete remission (CR) at four weeks who remain alive and never require additional therapy four weeks after the last dose of etanercept.
Complete remission is defined as the resolution of all manifestations of GVHD (Graft Versus Host Disease) within the first four weeks of treatment. All organs must have a Grade 0.
28 days No
See also
  Status Clinical Trial Phase
Terminated NCT01140984 - Intra Arterial (IA) Steroids Infusion for Hepatic Acute Hepatic Graft Versus Host Disease (aGVHD) N/A
Completed NCT00803010 - Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation Phase 2
Withdrawn NCT04280471 - Fecal Microbiota Transplantation for the Treatment of Severe Acute Gut Graft-Versus-Host Disease Phase 1
Withdrawn NCT02425813 - Methylprednisolone Sodium Succinate in Treating Patients With Acute Graft-versus-Host Disease of the Gastrointestinal Tract Phase 2
Terminated NCT00038792 - Phase I/II Trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD Phase 1/Phase 2
Terminated NCT04521777 - Studying Changes in Physical Function Measures in Stem Cell Transplant Patients at Risk for Steroid Myopathy N/A
Terminated NCT02436460 - A Study of AbGn-168H in Patients With Steroid Refractory Acute Graft-vs-Host Disease After Donor Stem Cell Transplant Phase 1
Not yet recruiting NCT01596192 - PETCT for Diagnosing and Monitoring Acute GVHD N/A
Recruiting NCT05823675 - Safety and Clinical Activity of Itolizumab in aGVHD Phase 1
Not yet recruiting NCT06386445 - Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT: Cohort Study
Recruiting NCT05443425 - Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies Phase 1
Recruiting NCT03158896 - Evaluation of Umbilical Cord-Derived Wharton's Jelly Stem Cells for the Treatment of Acute Graft Versus Host Disease Phase 1
Not yet recruiting NCT06444022 - hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation Early Phase 1
Active, not recruiting NCT04976699 - CD24Fc for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005) Phase 3
Terminated NCT04095858 - Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005) Phase 3
Terminated NCT00032773 - Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD Phase 1/Phase 2
Completed NCT02359929 - BMT Autologous MSCs for GvHD Phase 1
Withdrawn NCT00640497 - Anti-CD3 & Anti-CD7 Ricin A Immunotoxin-Combination for Acute Graft Versus Host Disease Phase 1/Phase 2
Completed NCT03491215 - Study of Pharmacokinetics, Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease Phase 1/Phase 2
Completed NCT02687646 - Clinical Trial With MSC for Graft Versus Host Disease Treatment Phase 1/Phase 2