Avatrombopag to Promote Platelet Engraftment After Allo-HSCT
- Registration Number
- NCT05143892
- Brief Summary
The purpose of the study is to evaluate the efficacy and safety of avatrombopag for the promotion of platelet engraftment after Allo-HSCT.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Avatrombopag Avatrombopag In the 4-weeks'study,the initial dose of avatrombopag is 20 mg/d. If the patient's PLT count remains less than 20\*10\^9/L after one week, the maximum dose was increased to 40 mg/d. Avatrombopag will be taken orally with food. Supportive care Supportive care Patients in this arm receive same treatment as in the avatrombopag group,except any TPO-RAs or recombinant human thrombopoietin.
- Primary Outcome Measures
Name Time Method Percentage of participants whose PLT reaches ≥ 20*10^9/L without the need for PLT transfusion. up to 4 weeks Accumulated platelet engraftment ratio
- Secondary Outcome Measures
Name Time Method Percentage of participants whose PLT reaches ≥ 50*10^9/L without the need for PLT transfusion. up to 4 weeks Accumulated complete platelet engraftment ratio
The time to achieve PLT ≥ 20*10^9/L without the need of PLT transfusion for consecutive 7 days (Defined as the first day when PLT ≥ 20×10^9/L without relying on platelet transfusion for 7 consecutive days ) up to 4 weeks time duration of platelet engraftment
Volume of PLT transfusion up to 4 weeks Volume of PLT transfusion
Hematopoietic reconstruction condition up to 4 weeks absolute neutrophils, hemoglobin
Trial Locations
- Locations (1)
The first affiliated hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China