Clinical Trial Goal
To find out:
- The highest dose of luspatercept that’s safe to give
- If luspatercept is safe and works well to treat anemia in children with beta-thalassemia
You may be able to join this trial if you:
Your child:
- Is 6 - 17 years old
- Has beta-thalassemia
- Has had blood transfusions of red blood cells at least 4 times in the last 6 months
- Has not gone more than 1.5 months without getting a blood transfusion of red blood cells in the last 6 months
- Has not been treated with an erythropoiesis-stimulating agent (ESA) in the last 6 months. Your child’s doctor can tell you this
- Has not been treated with hydroxyurea in the last 6 months
You agree to have other standard tests done to see if your child can be in the clinical trial
Trial Details
Luspatercept is a small molecule inhibitor that blocks TGF-beta in certain cells.
Your child will get:
Your child will get:
- Luspatercept – Given as a shot under your child’s skin 1 time every 3 weeks for up to 3 months. The dose your child will get depends on when they start the trial and how safe it has been
The clinical trial doctors will check your child’s health for up to 5 years.
The Food and Drug Administration (FDA) has approved luspatercept to treat anemia in adults with beta-thalassemia. Using it to treat anemia in children with beta-thalassemia is new and unproven.
Contacts
BMS Study Connect Contact Center www.BMSStudyConnect.com, 855-907-3286, Clinical.Trials@bms.com
First line of email MUST contain NCT # and Site #.
Locations
Local Institution - 601COMPLETED
Los Angeles, California
New York Presbyterian HospitalRECRUITING
New York, New York
Sujit Sheth, Site 602, 212-746-3400
Sponsors
collaborator: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA, lead: Celgene
