Actively Recruiting
Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD
Led by IRCCS San Raffaele · Updated on 2025-09-18
3
Participants Needed
2
Research Sites
558 weeks
Total Duration
On this page
Sponsors
I
IRCCS San Raffaele
Lead Sponsor
F
Fondazione Telethon
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Genetic diagnosis of X-CGD
- Age between 18 and 45 years
- Karnofsky Index greater than 80%
- Adequate heart, kidney, liver, and lung function
- Negative thrombophilic screen and no history of blood clots
- Signed informed consent
You will not qualify if you...
- Previous bone marrow transplant or gene therapy
- Use of other experimental drugs within 4 weeks (6 weeks for long-acting agents)
- Ongoing interferon-gamma treatment within 4 weeks
- Symptomatic inflammatory bowel disease
- Active viral, bacterial, or fungal infection within 6 weeks
- Cancer except for local skin cancer or family history of cancer
- Myelodysplasia or serious blood disorders
- History of uncontrolled seizures or deep vein thrombosis
- Other systemic diseases incompatible with the study
- Positive for HIV, HCV RNA, HbsAg, or HBV DNA
- Active alcohol or substance abuse in last 6 months
- Allergies or contraindications to Ibuprofen, G-CSF, Plerixafor, or Pantoprazole
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Ospedale Pediatrico Bambino Gesù
Rome, Lazio, Italy, 00165
Actively Recruiting
2
Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
Research Team
F
Fabio Ciceri, MD, PhD
CONTACT
A
Alessandro Aiuti, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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