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High-Risk or Hard to Treat Acute Graft Versus Host Disease Treatment Study
Allogeneic bone marrow or hematopoietic stem cell transplant (HSCT) is an effective immunotherapy for human cancer. When a patient receives a donor’s stem cells, the stem cells recreate the donor’s immune system in the patient’s body (“the host”).
A common side effect of allo-HSCTs is Graft-Versus-Host Disease (GVHD). It occurs when the new immune system from the donor attacks the host’s body. The donor cells see the host’s cells as “foreign” and attack them, which causes damage within the body. Acute GVHD develops in the first 100 days or so after the bone marrow transplant, but can also occur later. It primarily affects the skin, stomach, intestines, and liver.
It was recently identified that the level of a protein normally found throughout the body called epidermal growth factor (EGF) is very low in patients with severe acute GVHD as compared to transplant patients without acute GVHD. EGF stimulates normal cell growth of the skin and the lining of the gastrointestinal (GI) tract. It also is involved in the healing of damaged tissues. It is thought that adding EGF supplementation to the routine treatment plan might improve the healing of the tissues damaged by GVHD.
This study will use the EGF found in the drug Pregnyl, also known as hormone human chorionic gonadotropin (HCG). Pregnyl is approved by the U. S. Food and Drug Administration (FDA) to treat infertility in women as well as to treat testicle development issues in males. Its use in acute GVHD is considered investigational. The FDA has also approved administration of Pregnyl as an injection into a muscle (IM), and in this study it will be given as an under the skin injection to reduce the risk of bleeding.
Three groups of patients with GVHD are being treated in this study – Patients who have severe GVHD and who are within 7 days of starting treatment; patients with GVHD that is dependent on steroids; patients whose disease fails to respond to standard GVHD treatment. All three treatment arms will receive Pregnyl and test up to 7 dose levels.
In order to participate you must meet the following criteria:
- Have acute GVHD as determined by a University of Minnesota risk score or steroid-dependent acute GVHD or steroid resistant acute GVHD.
- Have adequate organ function.
You will be excluded from the study if any of the following criteria apply to you:
- Have a cancer that is growing, spreading or getting worse;
- Have a hormone responsive cancer;
- Have an uncontrolled infection or current blood clot disease requiring anticoagulation treatment.
- Are unable or unwilling to stop supplemental sex hormone therapy, such as estrogen, progesterone, and/or testosterone preparations.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.