Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease

• Status: Terminated
• Trial end date: 2016-09-26
• Target enrollment: 0
• Participant gender: All

Summary

Acute Graft Versus Host Disease (GVHD) is a serious medical condition that is a common development after Bone Marrow Transplant (BMT). Acute GVHD happens when the donor cells attack and damage your tissues and organs after transplant.

Acute GVHD often causes: Skin rashes, nausea, vomiting, abdominal pain, diarrhea (may have blood), liver damage that can cause inflammation in the liver or jaundice (yellowing of the skin or eyes), damage to other organs

Steroids are the first line of treatment for acute GVHD. About a quarter of the patients that develop acute GVHD may not respond to steroid and have steroid refractory GVHD (SR-aGVHD). Patients with SR-aGVHD may need other medications. SR-aGVHD, is a potentially life threatening condition. There is no standard treatment and it may not respond to treatment.

The goals of this study are to find out if Infliximab and basiliximab can treat SR-aGVHD.

Participants in this study will receive combination therapy (2 drugs: infliximab and basiliximab) once a week for four weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nationwide Children's Hospital
• Treatments: Antibodies; Antibodies, Monoclonal; Basiliximab; Immunoglobulins; Infliximab

Criteria

Inclusion Criteria:

• Any patient with either progressive aGvHD or Steroid Refractory aGvHD after Bone marrow transplant

• Prophylactic GvHD therapy with cyclosporine, tacrolimus, MMF, or sirolimus can be continued.

• Patients with late onset acute GvHD will be eligible

• Patients should have an absolute neutrophil count (ANC) of >500µL

• Patients with renal dysfunction or veno-occlusive disease are eligible

Exclusion Criteria:

• Patient should not be getting any other experimental therapy for aGvHD

• Patients with active uncontrolled life threatening infection (s) from viral, bacterial, fungal or other organisms will be excluded. Patients with HIV infection will be excluded

• Patients who are pregnant, breast feeding, or if sexually active and unwilling to use effective birth control for the duration of this study will be excluded

• Patients with NYHA Class III or IV heart failure will be excluded