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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 3 participants in total. It began in 2015-11-06 with a primary completion date of 2023-07-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 within 6 months of the study. * Contraindications to IBU, G-CSF, Plerixafor or Pantoprazole administration
Contact & Investigator
Fabio Ciceri, MD, PhD
PRINCIPAL INVESTIGATOR
Ospedale San Raffaele
Frequently Asked Questions
Who can join the NCT03055247 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 45 Years, studying Chronic Granulomatous Disease X-linked (X-CGD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03055247 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03055247 currently recruiting?
Yes, NCT03055247 is actively recruiting participants. Contact the research team at ciceri.fabio@hsr.it for enrollment information.
Where is the NCT03055247 trial being conducted?
This trial is being conducted at Rome, Italy, Milan, Italy.
Who is sponsoring the NCT03055247 clinical trial?
NCT03055247 is sponsored by IRCCS San Raffaele. The principal investigator is Fabio Ciceri, MD, PhD at Ospedale San Raffaele. The trial plans to enroll 3 participants.