Clinical Trial Goal
To find out if reduced intensity chemo and allogeneic BMT using either a haploidentical or unrelated donor is safe and works well to treat SAA that has not yet been treated
You may be able to join this trial if you:
- Are 3 - 75 years old
- Have SAA that has not yet been treated
- Have one of the following:
- A fully matched unrelated donor
- A family member who is your half match and can be your donor. Your biological parents and children are always a half-match for you.
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Anti-thymocyte globulin (ATG) and tacrolimus are standard drugs used to prevent GVHD.
Cyclophosphamide and fludarabine are chemo drugs that block the growth of cancer cells.
Granulocyte colony-stimulating factor (G-CSF) helps normal white blood cells recover from chemo.
Mycophenolate mofetil is a drug that slows down the immune system.
Cyclophosphamide and fludarabine are chemo drugs that block the growth of cancer cells.
Granulocyte colony-stimulating factor (G-CSF) helps normal white blood cells recover from chemo.
Mycophenolate mofetil is a drug that slows down the immune system.
Before transplant, you’ll get reduced-intensity treatment with the following:
- Antithymocyte globulin – Given as intravenous (IV) infusions 3 times
- Cyclophosphamide – Given as IV infusions 2 times
- Fludarabine – Given as IV infusions 5 times
- TBI
On transplant day, the blood-forming cells from your donor are given to you through an IV infusion.
After transplant, you’ll get:
- Cyclophosphamide – Given as IV infusions 2 times
- G-CSF - Given as IV infusions or as a shot under your skin 3 times
- Mycophenolate mofetil – You will receive for 1 month
- Tacrolimus – A pill you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
The clinical trial doctors will check your health for up to 1 year.
The Food and Drug Administration (FDA) has approved all of the treatments used in this trial. Using them in this way to treat SAA that has not yet been treated is new and unproven.
Locations
Sponsors
collaborator: National Heart, Lung, and Blood Institute (NHLBI), collaborator: National Cancer Institute (NCI), collaborator: Sanofi, lead: Medical College of Wisconsin
