Clinical Trial Goal
To find out if chemo and other drugs are safe and work well to treat Langerhans cell histiocytosis in children and teens
You may be able to join this trial if you:
Your child:
- Is 18 years old or younger
- Has Langerhans cell histiocytosis
You agree to have other standard tests done to see if your child can be in the clinical trial
Trial Details
The drugs your child will get during this trial depend on how severe their disease is and how well the treatment is working. The clinical trial doctors also might change the drugs your child gets during the trial, depending on how well the treatment is working. Some of these drugs are given by intravenous (IV) infusion and others are pills that your child will take by mouth.
Here are some of the drugs your child might get:
Here are some of the drugs your child might get:
- Cladribine
- Cytarabine
- Immunoglobulin
- Mercaptopurine
- Prednisolone
- Prednisone
- Vinblastine
If the clinical trial doctors think it's best for your child’s health, your child might have an allogeneic (cells from a donor) blood or marrow transplant (BMT). If this happens, blood-forming cells from a donor are given to your child through an IV infusion.
After about 6 months of treatment, depending how severe your child’s disease is and how well the treatment is working, your child might be randomized to 1 of 2 groups. Once your child is randomized, you and your child will be told which group they’re in:
- Group 1 – Indomethacin
- Group 2 – Mercaptopurine and methotrexate
Randomized means doctors will use a computer to assign your child to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your child, and your doctors won’t have any control over which group your child will be assigned. This means you won’t be able to choose your child’s group.
Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID).
Mercaptopurine and methotrexate are drugs that block growth of cancer cells.
If your child is in Group 1, they will get indomethacin, a pill taken 2 times per day.
If your child is in Group 2, they will get mercaptopurine, a pill taken 1 time per day. They will also get methotrexate, a pill taken 1 time per week.
The clinical trial doctors will check your child’s health for about 3 years.
The Food and Drug Administration (FDA) has approved all the drugs used in this trial. Using them together to treat Langerhans cell histiocytosis is new and unproven.
Contacts
Adrienne English, BSN, RN, Adrienne.English@stjude.org
Sara G Hastings, MBA, Sara.Hastings@stjude.org
Locations
Sponsors
collaborator: Histiocyte Society, lead: North American Consortium for Histiocytosis
