|MDACC Study No:||2012-0334 (clinicaltrials.gov NCT No: NCT01624805)|
|Title:||Phase II Study of Horse Anti-Thymocyte Globulin (hATG), Cyclosporine, Methylprednisolone, and GCSF (Filgrastim or Pegfilgrastim) in Patients with Aplastic Anemia (AA), or Low/Int-1 Risk Myelodysplastic Syndrome (MDS)|
|Principal Investigator:||Tapan Kadia|
|Treatment Agent:||Antithymocyte Globulin; CYCLOSPORIN A; G-CSF; Pegfilgrastim|
|Study Description:||The goal of this clinical research study is to learn if horse anti-thymocyte |
(hATG), given in combination with methylprednisolone, cyclosporine, and G-CSF
(filgrastim or pegfilgrastim), can help to control AA and/or low-int-1 risk
MDS. The safety of this drug combination will also be studied.
hATG is made from horse blood and targets immune cells known as T-lymphocytes.
Since T-lymphocytes are believed to be involved in causing low blood counts in
AA and in some cases of MDS, killing these cells may help treat the disease.
Methylprednisolone and cyclosporine work to suppress immune cells called
lymphocytes. This may help to improve low blood counts in AA and in some cases
Filgrastim and pegfilgrastim are designed to cause white blood cells to grow.
This may help to fight infections and help improve the white blood cell count.