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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT01770158
Eligibility Criteria:
Patient eligibility criteria in accordance to the summary of Product Characteristics:
* Patients with confirmed diagnosis of acute myeloid leukemia according to the World Health Organization (WHO) classification (including de novo AML, t-AML and s-AML) in first complete remission (defined as less than 5% blasts in a normocellular bone marrow assessed prior to the treatment start)
* AMLSG BiO participation incl. favourable opinion
* Presence of NPM1 mutation, CBFB-MYH11 or MLL-AF9 fusion genes as assessed in one of the central AMLSG reference laboratories.
* Measurable MRD values (non-negative values after consolidation therapy or increase in values over the threshold during follow-up in complete remission)
* The patient must be informed of the observation and written informed consent regarding data privacy obtained.
* Consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and all other treating physicians about observation participation
* No continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01770158
Study Brief:
Protocol Section:
NCT01770158