Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease
Condition: Graft Versus Host Disease; Steroid Refractory GVHD; Acute GVH Disease
MeSH terms: Graft vs Host Disease
Intervention: Infliximab and Basiliximab
Intervention description: Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks. Both drugs will be given through the participant's broviac, port or through a vein in the arm. It will take about 4-5 hours to complete the 2-drug combination therapy each week. Participants will be given pre-medications to help prevent reactions to the study drugs.
Infliximab will be given at a dose of 10mg per Kg per dose. Basiliximab will be given in 10mg doses to patients who weigh less than 35kg. Patients who weigh weigh more than 35kg will receive 20mg doses. Patients will receive both drugs weekly on days 1,8,15 and 22. Each drug will be given 4 times.
Intervention MeSH terms: Infliximab; Basiliximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 6 Months
Maximum age: 75 Years
Healthy volunteers: No
Keywords: aGVHD; GVHD; Graft versus host disease; Acute graft versus host disease; Steroid refractory graft versus host disease; Bone marrow transplant; BMT; HSCT; infliximab; basiliximab; Monoclonal antibody treatment

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.
    

Eligibility 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