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 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT01888458
Eligibility Criteria:
Inclusion Criteria:
* Adult patients receiving allo-Stem Cell Transplantation using Cord Blood as source of stem cells (cf conditioning regimen recommendation).
* Sex male or female
* Age between 18 and 65 years at the time of signing the informed consent form.
* Diagnosis of an hematologic disease for who a allograft decision has been taken
* not having a (HLA)-matched related or unrelated donor within two month after complete remission achievement
* Able to understand and voluntarily sign an informed consent form.
* Subjects affiliated with an appropriate social security system
* Male, female without childbearing potential or negative urine pregnancy test at the screening visit prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures. Men must agree to use an acceptable method of contraception (for themselves or female partners) for the duration of the study
* Each subject will weigh 40 kg or more
Exclusion Criteria:
* Any suspected or documented invasive fungal infection at study entry or at any time prior to study entry
* Use of any systemic antifungal therapy within 72 hours prior to study entry
* Known history of allergy, hypersensitivity or intolerance to echinocandin agents
* Patient with any medical, psychological or social condition, which in the opinion of the investigator could increase the risk to the patient, or decrease the chance of obtaining satisfactory data to achieve the objectives of this study.
* Participation in a study testing a new drug or a new conditioning
* HIV, HBV or HCV positive
* Pregnant or breast feeding females.
* Subject protected by law.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01888458
Study Brief:
Protocol Section:
NCT01888458