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Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD

NCT03055247 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-09-18

No results posted yet for this study

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.

Conditions

  • Chronic Granulomatous Disease X-linked (X-CGD)

Interventions

DRUG

Ibuprofen

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.

DRUG

Myelostim

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.

DRUG

Mozobil

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.

Sponsors & Collaborators

  • Fondazione Telethon

    collaborator OTHER

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Fabio Ciceri, MD, PhD · Ospedale San Raffaele

  • Franco Locatelli, MD, PhD · Ospedale Pediatrico Bambino Gesù

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-06
Primary Completion
2023-07-13
Completion
2026-07-18

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03055247 on ClinicalTrials.gov