Clinical Research Directory
Browse clinical research sites, groups, and studies.
Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD
Sponsor: IRCCS San Raffaele
Summary
This is a phase II exploratory study conducted to evaluate the safety and efficacy of the combination of Ibuprofen, G-CSF and Plerixafor as stem cell mobilization regimen in patients affected by X-CGD.
Official title: A Multicentric, Exploratory, Non-randomised, Non-controlled, Prospective, Open-label Phase II Study Evaluating Safety and Efficacy of IBU, G-CSF and Plerixafor as Stem Cell Mobilization Regimen in Patients Affected by X-CGD
Key Details
Gender
MALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
3
Start Date
2015-11-06
Completion Date
2026-07-18
Last Updated
2025-09-18
Healthy Volunteers
No
Interventions
Ibuprofen
Ibuprofen: 3 mg/kg tid (total daily dose: 9 mg/kg); administered orally from day 1 to day 5 and then from day 14 to the day before the last LP.
Myelostim
Myelostim (G-CSF): 5 µg/kg bid (total daily dose 10 µg/kg); administered subcutaneously from day 19 to the day of the last LP.
Mozobil
Mozobil (Plerixafor): 0,24 mg/kg daily. When CD34+ are ≥ 10 /μL Plerixafor will be administered subcutaneously from the next day (or from day 24 if CD34+ are \< 10 /μL) to the day of the last LP.
Locations (2)
Ospedale Pediatrico Bambino Gesù
Rome, Lazio, Italy
Ospedale San Raffaele
Milan, Lombardy, Italy