Study of Pharmacokinetics Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease

  • STATUS
    Recruiting
  • End date
    Feb 13, 2023
  • participants needed
    55
  • sponsor
    Novartis Pharmaceuticals
Updated on 26 May 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (3.2 mi away) Contact
+35 other location
platelet count
corticosteroids
myeloablative conditioning

Summary

The study is an open-label, single-arm, Phase I/II multi-center study to investigate the PK, activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in infants, children, and adolescents ages 28 days to <18 years old with either grade II-IV aGvHD or grade II-IV SR-aGvHD. This trial will utilize four age groups: Group 1 includes patients 12y to <18y, Group 2 includes patients 6y to <12y, Group 3 includes patients 2y to <6y, and Group 4 includes patients 28days to <2y.

Description

The study is an open-label, single-arm, Phase I/II multi-center study to investigate the PK, activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in infants, children, and adolescents ages 28 days to <18 years old with either grade II-IV aGvHD or grade II-IV SR-aGvHD. This trial will utilize four age groups: Group 1 includes patients 12y to <18y, Group 2 includes patients 6y to <12y, Group 3 includes patients 2y to <6y, and Group 4 includes patients 28days to <2y.

Details
Condition Acute Graft-versus-Host Disease, Acute GVHD, Acute Graft Versus Host Disease
Treatment Ruxolitinib
Clinical Study IdentifierNCT03491215
SponsorNovartis Pharmaceuticals
Last Modified on26 May 2021

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