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 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT01422603
Eligibility Criteria:
Inclusion Criteria:
* Cytologically and immunophenotypically (or immunohistochemically) confirmed diagnosis of high risk AML or MDS
* Minimum age of 18 years
* Eligible for allogeneic stem cell transplant by local institutional guidelines
* Suitable matched-related/sibling or volunteer unrelated donor available, as determined by local institutional guidelines
* Negative pregnancy test for females of child-bearing potential within 7 days prior to the start of study treatment
* If sexually active, male and female subjects must agree that they will use an effective method of birth control throughout the active study period
* Written informed consent
* Capable of and willing to comply with scheduled visits, treatment plan and required laboratory tests
* Adequate renal and hepatic function
Exclusion Criteria:
* Psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study
* Previous Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplant.
* Pregnant or lactating women. All female subjects of child-bearing potential must have a negative pregnancy test within 7 days prior to the start of treatment.
* Any current active, invasive malignancy excluding AML or MDS
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01422603
Study Brief:
Protocol Section:
NCT01422603