Avatrombopag to Promote Platelet Engraftment After Allo-HSCT

Study on Avatrombopag for the Promotion of Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation

The purpose of the study is to evaluate the efficacy and safety of avatrombopag for the promotion of platelet engraftment after Allo-HSCT.

Patients with thrombocytopenia (PLT<20×10^9/L) after allogenic hematopoietic stem cell transplantation (Allo-HSCT) who meet Eligibility Criteria were assigned into the avatrombopag group for 4 weeks' treatment.

Inclusion Criteria:

• Male or female, aged between 18-60 years;
• PLT<20×10^9/L after 14 days of allo-HSCT;
• Expected survival time > 3 months;
• ECOG performance status 0-2;
• Agree to receive the treatment of avatrombopag after Allo-HSCT and must sign the informed consent form.

Exclusion Criteria:

• Pregnant or lactating;
• With severe and uncontrollable infection;
• With graft-versus-host disease (GVHD) with steroid resistance;
• With thrombotic microangiopathy; With active thromboembolism requiring anticoagulation
• With detected disease recurrence due to chimerism by flow cytometry;
• With chronic active hepatitis B and C virus infection;
• With secondary or multiple transplantation, or multiple organ transplantation;
• With severe heart disease, lung disease, diabetes and metabolic diseases;
• HIV positive;
• With a history of PLT dysfunction or bleeding disorders
• With the active hepatic venous occlusion disease, or a history of clinically significant hepatic venous occlusion disease (The disease was defined as the abnormal condition of painful hepatomegaly after transplantation with bilirubin ≥ 6.0 mg/dL);
• With progressive solid tumor;
• With severe bleeding requiring transfusion of more than 2 units of red blood cells, or sudden drop of blood cell volume ≥10% within 7 days prior to screening;
• With any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study;
• With treatment of thrombopoietin receptor agonist (TPO-RA) one month before enrollment;
• Deemed unsuitable for enrollment by the investigator.