Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD
Recruiting now · Phase 2
Conditions studied: Chronic Granulomatous Disease X-linked (X-CGD)
In brief
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.
Key facts
- Study ID
- NCT03055247
- Run by
- IRCCS San Raffaele
- People needed
- 3
- Starts
- 2015-11-06
- Expected to finish
- 2026-07-18
- Last updated by the study team
- 2025-09-18
Who can join
Age: 18 and older, up to 45. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Previous Bone Marrow Transplantation or previous Gene Therapy.
- Use of other investigational agents within 4 weeks prior to study enrolment (within 6 weeks if use of long-acting agents).
- Ongoing IFN-γ treatment (within 4 weeks).
- Symptomatic inflammatory bowel disease.
- Symptomatic viral, bacterial, or fungal infection within 6 weeks of eligibility
- Neoplasia (except local skin cancer) or history of "familial" cancer
- Myelodysplasia or other serious hematological disorder
- History of uncontrolled seizures and deep venous thrombosis
- Other systemic disease judged as incompatible with the procedure
- Positivity for HIV and/or HCV RNA and/or HbsAg and/or HBV DNA
- Active alcohol or substance abuse within 6 months of the study.
- Contraindications to IBU, G-CSF, Plerixafor or Pantoprazole administration
Where it is running
- Ospedale Pediatrico Bambino Gesù — Rome, Lazio, Italy (enrolling)
- Ospedale San Raffaele — Milan, Lombardy, Italy (enrolling)
Full record on ClinicalTrials.gov
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