Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD
Recruiting
Phase 2Interventional Study
Chronic Granulomatous Disease X-linked (X-CGD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 45
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Basic Science
Participants needed
3 (estimated)
Sponsor
IRCCS San Raffaele · Other
Who this trial is looking for
This trial is looking for adults with X-linked Chronic Granulomatous Disease. Participants will receive a combination of treatments to help mobilize stem cells for their condition.
Are You a Good Fit for This Trial?
Rules you outNeoplasiaMyelodysplasiaSymptomatic viral infectionSymptomatic bacterial infectionSymptomatic fungal infection
You may be able to join if
I have a genetic diagnosis of X-CGD
I am between 18 and 45 years old
I have a Karnofsky Index greater than 80%
I have good heart, kidney, liver, and lung function
I have a negative thrombophilic screen
I can provide written consent
You may not be able to join if
I have had a bone marrow transplant or gene therapy before
I have used other investigational treatments in the past 4 weeks
I am currently receiving IFN-γ treatment
I have inflammatory bowel disease
I have a recent infection within the last 6 weeks
I have a history of uncontrolled seizures
I am positive for HIV or Hepatitis C
I have a history of substance abuse in the last 6 months
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 …
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
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