Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD

PHASE2RecruitingINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

November 6, 2015

Primary Completion Date

July 13, 2023

Study Completion Date

July 18, 2026

Conditions
Chronic Granulomatous Disease X-linked (X-CGD)
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (2)

20132

RECRUITING

Ospedale San Raffaele, Milan

00165

RECRUITING

Ospedale Pediatrico Bambino Gesù, Rome

All Listed Sponsors
collaborator

Fondazione Telethon

OTHER

lead

IRCCS San Raffaele

OTHER