Maraviroc as GVHD Prophylaxis in Transplant Recipients

Stopped early · Phase 1/Phase 2

Conditions studied: Diagnoses That Require Stem Cell Transplant, Graft Versus Host Disease (GVHD)

In brief

The purpose is to determine if the addition of Maraviroc to a standard transplant regimen will reduce the incidence of graft versus host disease in children and young adults after a stem cell transplant.

Key facts

Study ID

NCT02167451

Run by

Children's Hospital Medical Center, Cincinnati

People needed

31

Starts

2014-07-01

Expected to finish

2018-09-01

Last updated by the study team

2020-03-10

Who can join

Age: 5 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 5 years and </= 40 years
• All diagnoses
• Peripheral blood stem cells, marrow or cord blood
• All conditioning regimens
• Patient must be planned to receive a calcineurin inhibitor (cyclosporine or tacrolimus) together with steroid, methotrexate or mycophenolate mofetil as GVHD prophylaxis.

You may not qualify if…

• Documented anaphylaxis to Maraviroc
• Ex vivo T-cell (type of white blood cell) depleted grafts
• Abnormal Alanine Aminotransferase (ALT) (>/=10X ULN) on day -3. (Assessed at study enrollment and confirmed again prior to the first dose of maraviroc.)

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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