Clinical Trial Goal
To find out if the combination of the drugs hATG, methylprednisolone, cyclosporine, and either filgrastim or pegfilgrastim is safe and works well to control AA or MDS
You may be able to join this trial if you:
- Are 18 years old or older
- Have AA or low/intermediate risk MDS
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
At the beginning of the study, you'll stay in the hospital for 4 – 5 days. You'll get hATG as an intravenous (IV) infusion 1 time each day for 4 days. Each infusion takes about 8 hours.
You will also receive 3 drugs to slow down your immune system and help your bone marrow grow healthy cells:
You will also receive 3 drugs to slow down your immune system and help your bone marrow grow healthy cells:
- Methylprednisolone – An IV infusion given 1 time each day for 4 days, then by IV infusion or as a pill that you take by mouth 1 time each day for about 3 weeks
- Cyclosporine – A pill given 2 times each day. You will take this for 6 months.
- Pegfilgrastim or filgrastim – A shot given under the skin. If you get pegfilgrastim, you’ll get a shot under the skin 1 time after 5 days. If you get filgrastim, you’ll get a shot 1 time each day starting on after 5 days for as long as the clinical trial doctors think you need it.
You may continue treatment for up to 6 months. You'll have biopsies to see how well treatment is working. The clinical trial doctors will check your health for up to 6 years.
The Food and Drug Administration (FDA) has approved hATG for treating AA, but it has not yet been approved for treating MDS.
Locations
M D Anderson Cancer CenterRECRUITING
Houston, Texas
Tapan M. Kadia, 713-563-3534, tkadia@mdanderson.org
Sponsors
collaborator: National Cancer Institute (NCI), lead: M.D. Anderson Cancer Center
