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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03547830 |
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Date of registration:
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24/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Plerixafor/G-CSF as Additional Agents for Conditioning Before HSCT in CGD Patients
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Scientific title:
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A Clinical Trial of Plerixafor With G-CSF as Additional Agents in Conditioning Regimen for Prevention of Graft Failure in Patients With Chronic Granulomatous Disease |
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Date of first enrolment:
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April 13, 2019 |
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Target sample size:
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17 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03547830 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Zhanna Shekhovtsova, MD |
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Address:
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Telephone:
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4956647078 |
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Email:
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zhanna.shekhovtsova@fccho-moscow.ru |
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Affiliation:
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Name:
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Dmitry Balashov, MD |
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Address:
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Telephone:
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+79265791817 |
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Email:
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bala8@yandex.ru |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients aged = 1 months and < 25 years Patients diagnosed with CGD eligible for an
allogeneic transplantation Signed written informed consent
Exclusion Criteria:
Lack of informed consent.
Age minimum:
1 Month
Age maximum:
24 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Granulomatous Disease
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Intervention(s)
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Drug: Plerixafor
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Drug: Gcsf
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Primary Outcome(s)
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Event free survival
[Time Frame: 1 year]
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Secondary Outcome(s)
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3. Transplant related mortality
[Time Frame: 1 year]
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1. Overall survival
[Time Frame: 1 year]
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Proportion of patients with full/mixed donor chimerism
[Time Frame: 30 days]
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4. Acute Graft Versus Host Diseases
[Time Frame: 100 days]
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5. Incidence of Plerixafor related toxicity
[Time Frame: 100 days]
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Secondary ID(s)
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NCPHOI-2018-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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