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Allogeneic (cells from a donor) blood or marrow transplant (BMT) and a drug, alemtuzumab, to treat blood or immune system diseases in children, teens and young adults

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Phase 2

1 Location

NCT05501756

Clinical Trial Goal


To find out: 
  • The best dose of alemtuzumab that’s safe to give before allogeneic BMT
  • If allogeneic BMT and alemtuzumab is safe and works well to treat blood or immune system diseases in children, teens and young adults 

You may be able to join this trial if you:


Your child:
  • Has has a blood or immune system disease that's not a blood cancer. Some examples include:
    • Adrenoleukodystrophy (ALD)
    • Aplastic anemia
    • Hurler syndrome
    • Krabbe disease
    • Metachromatic leukodystrophy (MLD)
    • Severe combined immunodeficienty
    • Sickle cell disease
    • Wiskott-Aldrich syndrome 

You agree to have other standard tests done to see if your child can be in the clinical trial 

Trial Details


Alemtuzumab is a monoclonal antibody that targets CD52 on certain cells. Doctors think that having a certain level of alemtuzumab in the body on transplant day will help people have fewer side effects from transplant. 

Before transplant, your child will get:
  • Alemtuzumab – Given 1 time each day for 3 days about 2 weeks before transplant

On transplant day, the blood-forming cells from your child's donor are given to them through an IV infusion.

Your child will have blood tests to see how well the treatment is working. The clinical trial doctors will check your child's health for 100 days. 

The Food and Drug Administration (FDA) has approved alemtuzumab to treat several disease. The best dose before allogeneic transplant is not known.  

Contacts


Caitlin Cottrell, 513-803-7039, Caitlin.Cottrell@cchmc.org

Richard Cooper, richard.cooper@cchmc.org

Locations


Cincinnati Children's Hospital Medical CenterRECRUITING

Cincinnati, Ohio
Contacts:

ClinicalTrials.gov record


NCT05501756. First posted on 8/15/22

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