Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD
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
IRCCS San Raffaele
3 participants
Nov 6, 2015
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- Genetic diagnosis of X-CGD
- 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 Criteria12
- 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
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Interventions
Ibuprofen: 3 mg/kg tid (total daily dose: 9 mg/kg); administered orally from day 1 to day 5 and then from day 14 to the day before the last LP.
Myelostim (G-CSF): 5 µg/kg bid (total daily dose 10 µg/kg); administered subcutaneously from day 19 to the day of the last LP.
Mozobil (Plerixafor): 0,24 mg/kg daily. When CD34+ are ≥ 10 /μL Plerixafor will be administered subcutaneously from the next day (or from day 24 if CD34+ are \< 10 /μL) to the day of the last LP.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03055247