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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT02267993
Eligibility Criteria:
Inclusion Criteria:
1. Age of 18-55 years;
2. Patients that meet the diagnostic criteria of acute myeloid leukemia (except M3 and M7 subtypes), and achieve complete remission following induction chemotherapy and undergo consolidation therapy;
3. Patients who require two successive cycles of DA (Ara-c 1.5 g/m2/q12 h and DNR 40 mg/m2/d on days 1-3) or MA regimen (Ara-C 1.5 g/m2/q12 h and MTZ 6 mg/m2/d on days 1-3) at the phase of consolidation therapy, or underwent consolidation therapy with administration of Ara-C 3 g/m2/q12 h alone, with dose adjustment of less than 10% Ara-C dose;
4. Patients with the minimum platelet count of \< 30´109/L at the final cycle of chemotherapy during the induction stage;
5. Patients without apparent liver or renal dysfunctions (serum levels of urea nitrogen, creatinine, aminotransferase and bilirubin were all ≤ 1.5 times of the normal upper limit);
6. Patients without severe heart or lung dysfunctions;
7. Patients with life expectancy of \> 12 weeks;
8. Patients with ECOG score of ≤ 2;
9. Patients are willing to participate in the study and sign the informed consent.
Exclusion Criteria:
1. Patients with a medical history of severe allergy to biologics;
2. Patients with thromboembolic or hemorrhagic disease, or a recent medical history of thrombosis;
3. Patients with a history of mental disorders;
4. Pregnant or lactating patients, or patients with failure in use of contraception during the study period;
5. Patients with M3 or M7 subtype;
6. Patients with a platelet count of 1000 ´109/L at the start of the study;
7. Patients with other factors which were considered not to be suitable to participate in the study by the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02267993
Study Brief:
Protocol Section:
NCT02267993