Acute Myeloid Leukemia, Thrombocytopenia
Conditions
Interventions
Control group:Placebo
After the completion of the first consolidation chemotherapy with high-dose cytarabine (cytarabine three-day chemotherapy), the placebo 75mg/day was started on Day +1 and continu
experimental group:Eltrombopag
After the completion of consolidation chemotherapy with high-dose cytarabine (cytarabine three-day chemotherapy) for the first time, start using Eltrombopag 75mg/day on
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged 18 to 65 years (inclusive); 2.Patients diagnosed with acute myeloid leukemia according to the WHO classification, who have achieved complete remission and are scheduled to receive intermediate-dose cytarabine as their first consolidation therapy; 3.KPS score >= 70; 4.The absolute platelet count before the first consolidation chemotherapy is not less than 100 × 10?/L; 5.Expected survival time >= 6 months; 6.Voluntarily participate in the trial, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects with known allergies to eltrombopag or any of its excipients. 2.Patients with thrombocytopenia due to other causes, such as chronic liver disease, splenomegaly, infection, or bleeding. 3.Subjects who require the use of other platelet-elevating agents (IL-11, rhTPO, other Chinese patent medicines that increase platelet counts, etc.) during the treatment period. 4.Pregnant or breastfeeding female patients. 5.Patients with significant dysfunction of vital organs such as the heart, lungs, liver, or kidneys: liver function indicators (ALT, TBil) > 2.5 × ULN, creatinine clearance < 50 mL/min; subjects with a history of severe cardiovascular disease (e.g., NYHA class III/IV congestive heart failure, arrhythmias that increase the risk of thromboembolic events [such as atrial fibrillation], and angina pectoris; subjects who have undergone coronary stent replacement, angioplasty, or coronary artery bypass grafting; "Caprini score = 6 (high thrombotic risk)", "use of anticoagulant/antiplatelet agents within the past 3 months that cannot be discontinued", "Child-Pugh class B or higher liver function", etc.). 6.Previous history of arterial or venous thrombosis. 7.Subjects who have participated in another clinical study and received any investigational drug or device within 30 days prior to the baseline visit; however, participation in observational studies is permitted. 8.Other conditions that, in the investigator's judgment, make the subject unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with platelet count >= 50×10^9/L who are free from platelet transfusion for 3 consecutive days or more.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of bone marrow assessments with a blast percentage >= 5%;Proportion of bleeding of grade >= 3;Proportion of confirmed thrombotic events within 360 days.;The number of treatment sessions requiring platelet transfusion.;Proportion of patients with platelet count >= 20×10^9/L who are free from platelet transfusion for 3 consecutive days or more.;Proportion of patients with platelet count >= 50×10^9/L who are free from platelet transfusion for 3 consecutive days or more.;The proportion of ALT/AST >= 3×ULN or bilirubin >= 2×ULN; | — |
Countries
China
Contacts
Public ContactChen Siliang
Peking University Shenzhen Hospital
Outcome results
None listed