Purpose of study:
Acute GVHD is a serious medical condition that is a common development after Bone Marrow transplant. Acute GVHD happens when the donor cells attack and damage your tissues and organs after transplant. Acute GVHD often causes:
Steroids are the first line of treatment for acute GVHD. About a quarter of the patients that develop Acute GVHD may not respond to steroids 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 combination drug therapy can treat SR-aGVHD.
Who can participate:
Patients between the ages of 6 months-75 years of age can participate.
Any patient with progressive Acute GVHD or Steroid Refractory GVHD can participate.
Patients with Refractory GVHD after Stem Cell or Bone Marrow Transplant can participate.
Patients may continue taking cyclosporine, tacrolimus, MMF, or sirolimus.
Patients should have an absolute neutrophil count (ANC) of greater than 500µL.
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 unable to give informed consent for the study will be excluded.
What will happen during the study:
Before you join the study, we will ask you about your medical history, and any medications you may be taking. It is important that you do not participate in the study if you are pregnant, breastfeeding or are likely to become pregnant during the study.
Your doctor will do a number of tests to determine if you are able to participate in this study. These tests include:
If you decide to participate in this research study, you will receive the combination therapy once a week for four weeks. The medicines will be given through your broviac, port or through a vein in your arm. It will take about 4 or 5 hours to complete the 2-drug combination therapy each week. You will be given some medications first to help prevent any reactions to the study drugs.
Once you finish the 4 weeks of study treatment, we will evaluate you weekly, then monthly, and as your condition improves the team will evaluate you less often. The study team will follow your health for up to 12 months after you first joined the study. During these visits, the team will evaluate your:
Who to contact: