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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT06648512
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged 18 years or older.
2. Signed informed consent form that permits use of sample in the proposed study (including permission for genetic analysis).
3. Sample of a newly diagnosed patient (sample at time point diagnosis); after interim analysis the population may include samples from patients with FLT3 mutated relapsed/refractory AML.
4. The sample may not be older than 5/ 10 years (depending on location)
5. Confirmed diagnosed AML according to WHO or ICC criteria; after interim analysis the population may include FLT3 mutated R/R AML according to ELN 2022 criteria after interim analysis.
6. Patient received one of the following therapies after sampling for which response data is available:
1. 7 + 3 (with or without additional GO or TKIs)
2. CPX-351
3. Venetoclax and AZA in combination or alone
4. If R/R AML, FLT3 mutated: treated with Gilteritinib
7. Characteristics of sample taken prior to therapy as specified in the study protocol.
8. Availability of complete dataset as specified in the study protocol.
Exclusion Criteria:
1. Known or suspected HIV or active Hepatitis B and/or C infection or active COVID-19 infection (if information not available, samples can still be included) at time of sample collection.
2. Known active infection of bone marrow.
3. Known pregnancy.
4. Received systemic anticancer treatment or radiotherapy within 4 weeks of sampling (pre-treatment of hydroxyurea and/or low dose cytarabine allowed).
5. Patient is diagnosed with Acute Promyelocytic Leukaemia (APL).
6. Patients with treatment for any other oncologic neoplasm at time of sample collection.
7. Patients for whom CR could not be assessed (e.g. death before re-staging).
8. Inclusion of samples from the same patient at both diagnosis and relapse is not permitted. In such cases, only the diagnostic sample is to be used.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06648512
Study Brief:
Protocol Section:
NCT06648512