RecruitingPhase 2NCT03055247

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

Sponsor

IRCCS San Raffaele

Enrollment

3 participants

Start Date

Nov 6, 2015

Study Type

INTERVENTIONAL

Conditions

Chronic Granulomatous Disease X-linked (X-CGD)

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

Sex: MALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ibuprofen, a drug called Mozobil, and others for people with chronic granulomatous disease x-linked (x-cgd). The study is currently recruiting participants at 2 locations. People eligible for this study include men aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIbuprofen

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.

DRUGMyelostim

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.

DRUGMozobil

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)

Ospedale Pediatrico Bambino Gesù

Rome, Lazio, Italy

Ospedale San Raffaele

Milan, Lombardy, Italy

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NCT03055247