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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT04150393
Eligibility Criteria:
Inclusion Criteria:
1. Male or Female
2. Age ≥ 18 years
3. Patients diagnosed with AML defined according to WHO 2016 criteria with ≥20% leukemic blasts in the bone marrow or with high- risk myelodysplastic syndrome, receiving intensive chemotherapy
4. Patients healthy enough to likely receive their consolidation or second cycle of chemotherapy after induction chemotherapy
5. Patients healthy enough to likely receive HSCT
6. Informed written consent
7. Patient recovered from neutropenia
Exclusion Criteria:
1. Acute promyelocytic leukemia (AML-M3)
2. AML secondary to myeloproliferative disorder or chronic myelomonocytic leukemia (CMML)
3. Acute myeloid leukemia BCR-ABL1+
4. Active CNS leukemia
5. Patients with a life expectancy of \<70 days according to investigator's opinion, or subject to therapeutic limitations
6. Confirmed or suspected intestinal ischemia
7. Confirmed or suspected toxic megacolon or gastrointestinal perforation
8. Active uncontrolled infection according to the attending physician
9. Any gastro-intestinal bleeding in the past 3 months
10. Any history of gastro-intestinal surgery in the past 3 months
11. Any history of inflammatory bowel disease
12. Any counter-indication to swallow capsules
13. Enrollment in another trial that may interfere with this study
14. Known allergy or intolerance to trehalose, maltodextrin or PEG
15. Women of childbearing potential without efficient contraceptive protection
16. Pregnant or breastfeeding
17. Patients with EBV-negative serology
18. Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
19. Exclusion period of a previous study
20. Administrative or legal supervision
21. Confirmed positive result to SARS-CoV-2 nasopharyngeal test at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04150393
Study Brief:
Protocol Section:
NCT04150393