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 @ 1:15 PM
Ignite Modification Date:
2025-12-24 @ 1:15 PM
NCT ID:
NCT02750995
Eligibility Criteria:
Inclusion Criteria:
1. Participants must have received 6 courses of azacitidine and been evaluated with response to treatment.
2. Histologically confirmed high-risk MDS or AML (\<30% blasts) and a normo- or hypercellular marrow after 6 courses of azacitidine.
3. Indication for continued treatment with azacitidine.
4. Age \>18 years.
5. Signed consent form after receiving both written and oral information.
6. The patients must be willing to follow the scheduled treatment and sampling.
Exclusion Criteria:
1. Hypocellular bone marrow after 6 courses of azacitidine.
2. Additional active cancer disease. Participants treated for a second malignancy may be included if the patient is without evidence of disease at least 2 years after completion of treatment.
3. Participants with a known hypersensitivity to any of the active substances or to any of the excipients.
4. Participants with secondary MDS or AML
5. Severe allergies or previous anaphylactic reactions.
6. Active autoimmune disease, for example autoimmune neutropenia/ thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, Sjögren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, Addison's disease, Hashimoto's thyroiditis, Grave's disease.
7. Concomitant treatment with systemic immunosuppressive medications (including prednisone, methotrexate etc.). Participants are allowed to receive up to 10 mg prednisone at the days of azacitidine injection.
8. Concomitant treatment with other experimental drugs.
9. Concomitant treatment with other systemic anti-cancer therapy.
10. Pregnant or breastfeeding females.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02750995
Study Brief:
Protocol Section:
NCT02750995