Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia (H-CIT-AML)
Chemotherapy-Induced Thrombocytopenia
About this trial
This is an interventional treatment trial for Chemotherapy-Induced Thrombocytopenia focused on measuring Chemotherapy-Induced Thrombocytopenia, Acute Myeloid Leukemia, Hetrombopag
Eligibility Criteria
Inclusion Criteria: Ages 18-70; Participant with a histologically or cytologically confirmed acute myeloid leukemia in complete remission (PLT≥100×109/L) (except acute promyelocytic leukemia); Participant who have completed induction therapy and achieved complete remission, have received ≤1 course of intensive consolidation chemotherapy, and will continue to receive intensive consolidation or maintenance chemotherapy; Intensive chemotherapy after complete remission including: high-dose or medium-dose cytarabine chemotherapy (1-1.5g/m2 q12h×3 days), standard-dose chemotherapy (cytarabine combined with anthracycline/anthraquinones, HHT, pohyllotoxin, etc.); Participant whose Expected survival time ≥3 months, and who can receive at least 2 cycles of intensive chemotherapy; ECOG performance status <=2; Participants of childbearing age who agree to use reliable contraceptive methods; Patients signed the informed consent form and volunteered to participate in this study with good compliance; Exclusion Criteria: Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia; Participant has a history of arterial or venous thrombosis within 6 months before screening (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), or has clinical symptoms and medical history suggestive of thrombophilia; Participant has a history of severe cardiovascular disease within 6 months before screening, such as congestive heart failure (NYHA class III-IV), arrhythmia known to increase the risk of thromboembolism (atrial fibrillation), post-coronary stent implantation, angioplasty, or coronary artery bypass grafting; Known human immunodeficiency virus infection,or hepatitis C infection (if hepatitis B surface antigen is positive, or hepatitis B surface antigen is negative but hepatitis B core antibody is positive, HBV-DNA testing is required, if virus replication is suggested, the subject should be excluded); Abnormal liver function (TBL>3xULN; alanine aminotransferase [ALT] or aspartate aminotransferase [AST]>3xULN); Abnormal renal function with serum creatinine>1.5xULN or creatinine clearance ≤ 60 ml/min using Cockcroft-Gault estimated creatinine clearance; Pregnant or lactating women, or those planning to receive/give birth in the near 6 months; Participant participated in other clinical trials within 3 months before enrollment; Previous use of thrombopoietin receptor agonist (TPO-RA), recombinant human TPO, recombinant human interleukin-11(rhlL-11) within 1 month before screening; Received platelet transfusions within 3 days before enrollment; Patients with known or expected allergy or intolerance to the active ingredient or excipients of hetrombopag; Inability to understand the nature of the study or failure to obtain informed consent; The investigator considers that there are any other conditions that may prevent the subject from completing the study or present a significant risk to the subject;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Hetrombopag
Control
The study in a 1:1 randomization ratio (36 subjects to experimental group). The treatment group received Herteppa Ethanolamine tablets and platelet transfusion.
The study in a 1:1 randomization ratio (36 subjects to control group). The control group did not receive other platelet raising therapy except platelet transfusion.