NCT03055247 Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD
| NCT ID | NCT03055247 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | IRCCS San Raffaele |
| Condition | Chronic Granulomatous Disease X-linked (X-CGD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2015-11-06 |
| Primary Completion | 2023-07-13 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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