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:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-24 @ 8:00 PM
NCT ID:
NCT03434704
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of myelodysplastic syndromes or acute leukemia
* Activation of an alternative donor search by the Italian Bone Marrow Donor Registry (IBMDR) with absence of a 10/10 Human Leukocyte Antigens (HLA) matched unrelated donor
* Age \>18
* Unavailability of a HLA-matched related donor (MRD)
* Performance status : Eastern Cooperative Oncology Group (ECOG) \<3
* Written and signed informed consent
* Life expectancy not severely limited by concomitant illness.
Exclusion Criteria:
* Women of child-bearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), vasectomised partner on treatment and for at least 6 months thereafter.
* Pregnant or nursing (lactating) women.
* Known allergies, hypersensitivity, or intolerance to any experimental drugs.
* Any active, uncontrolled infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03434704
Study Brief:
Protocol Section:
NCT03434704