Maraviroc as GVHD Prophylaxis in Transplant Recipients

• Status: Terminated
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Maraviroc

Criteria

Inclusion Criteria:

• Ages 5 years and
• 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.

Exclusion Criteria:

• 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.)