NCT02167451|TerminatedPhase 1/2ResultsDMC
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slow recruitment and no further drug supply
Maraviroc as Graft Versus Host Disease Prophylaxis in Pediatric and Adult Stem Cell Transplant Recipients
Sponsor study identifier
interventional
31
1 country
1
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2018
Actual (reported)Study Completion
September 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 13, 2014
Actual (reported)June 19, 2014
Actual (reported)July 2014
Date type not reportedThis date has not been verified as actual or estimated.
September 2018
Actual (reported)September 2018
Actual (reported)March 10, 2020
Actual (reported)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.
Up to day +100
GVHD Incidence
Incidence of GVHD by day+100
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
Day 0
Incidence of Visceral GVHD
determine the number of patients who develop visceral GVHD by day+100
day+100
Overall Survival
By day +100
Graft Failure
By day +100
Primary Disease Relapse
By day +100
Toxicities
Up to day +100
Infectious Complications
Up to day +100
Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
early termination leading to small number of subjects analyzed.
Pooja Khandelwal, MD
Children's Hospital Medical Center, Cincinnati
31 participants (actual enrollment reported by the registry).
First Submitted
June 13, 2014
First Posted
June 19, 2014
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
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
Day 10
Contact the study team to confirm eligibility.
Primary Completion
September 2018
Actual (reported)Study Completion
September 2018
Actual (reported)Last Updated
March 10, 2020
Results First Posted
March 10, 2020
Record last verified: 2020-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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