Hetrombopag for the Enhancement of Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation
Hematological Disease, Allogeneic Hematopoietic Stem Cell Transplantation
About this trial
This is an interventional treatment trial for Hematological Disease
Eligibility Criteria
Inclusion Criteria: The patients signed the informed consent and participated in the study voluntarily; Age ≥ 18 years old, regardless of gender; ECOG score ≤ 2; Expected survival ≥ 3 months; Patients with hematological diseases who received allo-HSCT for the first time; The patient's laboratory tests met the following criteria: Alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN), Aspartate aminotransferase (AST) ≤ 3.0 × ULN; Serum total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN; Investigators evaluated that patients would benefit from hetrombopag. Exclusion Criteria: History of allergy to TPO-RA drugs; Previous bone marrow or hematopoietic stem cell transplantation; Hematologic malignancies did not reach complete remission before transplantation; Central nervous system leukemia; Arterial or venous thrombosis, such as cerebral infarction, pulmonary embolism, arterial thrombosis, deep venous thrombosis and disseminated intravascular coagulation (DIC), occurred within 6 months before the screening period; Heart disease, such as New York Heart Association (NYHA) class III/IV congestive heart failure, angina pectoris, myocardial infarction, and arrhythmias requiring treatment, occurring within 6 months before the screening period; Prolonged QT syndrome during the screening period; Active hepatitis B or hepatitis C; Positive for anti-HIV antibodies or anti-TP antibodies; Active infection that is difficult to control; Pregnant or breastfeeding women; Other conditions not suitable for inclusion evaluated by the investigator.
Sites / Locations
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
hetrombopag group (Experimental group)
Control group
After hematopoietic stem cell reinfusion, the patients begin to take hetrombopag orally 7.5mg/d, until the patients reach complete platelet response (CR, platelet count ≥50×109/L for 3 consecutive days without platelet transfusions for 7 consecutive days). The treatment will stop when patients accept 21 consecutive days of treatment or reach the discontinuation criteria.
After hematopoietic stem cell transfusion, the patients will be only observed, and the observation during the treatment period will be ended after 30 days.