Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT02678533
Eligibility Criteria:
Inclusion Criteria:
* Patient with Fanconi anemia
* Patient from 2 to 17 years old
* Potential indication for allogenic bone arrow graft without HLA-identical brotherhood available
* Patient's weight \>10kg
* Treated and followed for at least the previous two years in a specialized center where they got a full assessment of their disease
* For women of childbearing age, not pregnant and use of an effective contraception during the entire participation in the research.
* Affiliated or beneficiary of an health insurance regimen
* Informed and signed consent
Exclusion Criteria:
* Patient unable to follow the visits required by the protocol
* Positive serology for HIV-1/2, HTLV-1/2, HCV and HbS
* Bacterial, viral, fungal or parasitic active infection with clinical signs
* Personal history of cancer, myeloproliferative hematopathy or immune deficiency
* Heart failure and / or heart rhythm disorder
* History of allogeneic graft of hematopoietic stem cells
* Patient with an HLA-identical brotherhood donor available
* Myelodysplasia diagnose on myelogram
* Cytogenetic abnormality on karyotype
* Malignant solid tumor
* Documented spontaneous genetic reversion of medullary process
* Diagnosis of a psychiatric disorder that could compromise his/her ability to participate in the study
* Any disorder according to the investigator, that could compromise the ability of patient to give his writing consent and/or to comply with requiring study's procedures
* Current Pregnancy
* Heart, kidney or liver failure
* Current participation in another interventional clinical trial
* Patient under Medical Assistance State
* Hypersensitivity to plerixafor or any excipient contained in MOZOBIL®
* Hypersensitivity to filgrastim or any of its' excipient
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT02678533
Study Brief:
Protocol Section:
NCT02678533