Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia

Korábbi kezelés

• 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;
• 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;

Más betegség

• Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
• 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);
• 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;

Laborértékek

• 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;
• Received platelet transfusions within 3 days before enrollment;

Egyéb

• Pregnant or lactating women, or those planning to receive/give birth in the near 6 months;

• 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;