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.
In the first stage, drug levels will be obtained to establish appropriate dosing. In the second stage of the study the investigators will study the effects of using Maraviroc in these patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
31
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Feasibility of Maraviroc
The ability to administer twice daily oral maraviroc in children and adults undergoing stem cell transplant in addition to routine standard graft versus host disease prophylaxis.
Time frame: Up to day +100
GVHD Incidence
Incidence of GVHD by day+100
Time frame: By day +100
Area Under The Concentration-Time Curve (AUC) of Maraviroc
pK target \>100ng/ml at day zero at the following time points : before the dose and 1, 2, 4, 6, 8, and 12 hours after maraviroc administration
Time frame: Day 0
Incidence of Visceral GVHD
determine the number of patients who develop visceral GVHD by day+100
Time frame: day+100
Area Under The Concentration-Time Curve (AUC) of Maraviroc
pK target \>100ng/ml at day 10 at the following time points : before the dose and 1, 2, 4, 6, 8, and 12 hours after maraviroc administration
Time frame: Day 10
Overall Survival
Overall survival for patients who were enrolled and received maraviroc
Time frame: By day +100
Graft Failure
Failure to engraft and loss of graft.
Time frame: By day +100
Primary Disease Relapse
Time frame: By day +100
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Toxicities
Incidence of toxicities due to drug
Time frame: Up to day +100
Infectious Complications
Infections complications which include asymptomatic viremias for EBV, Adenovirus, CMV, and/or viral disease, bacterial and fungal infections as documented by blood cultures.
Time frame: Up to day +100
Time to Neutrophil
Neutrophil engraftment is defined as the first of three consecutive measurements of ANC\>500mcL over 3 or more days.
Time frame: Up to day +100
Time to Platelet Engraftment
Time to achieve platelets count of 20,000 without transfusions
Time frame: days