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
Who is this study for? Patients with Chronic Granulomatous Disease X-linked (X-CGD)
What treatments are being studied? Ibuprofen+Myelostim+Mozobil
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:
• Genetic diagnosis of X-CGD
• 18-45 years of age
• Karnofsky Index \> 80 %
• Adequate cardiac, renal, hepatic and pulmonary function.
• Negative thrombophilic screen and negative history for previous thrombotic events
• Written informed consent
Locations
Other Locations
Italy
Ospedale San Raffaele
RECRUITING
Milan
Ospedale Pediatrico Bambino Gesù
RECRUITING
Rome
Contact Information
Primary
Fabio Ciceri, MD, PhD
ciceri.fabio@hsr.it
39 02.2643.3903
Backup
Alessandro Aiuti, MD, PhD
aiuti.alessandro@hsr.it
+390226434875
Time Frame
Start Date: 2015-11-06
Estimated Completion Date: 2026-07-18
Participants
Target number of participants: 3
Treatments
Experimental: XCGD mobilization
Treatment with combination of Ibuprofen, Myelostim and Mozobil
Related Therapeutic Areas
Sponsors
Leads: IRCCS San Raffaele
Collaborators: Fondazione Telethon