Delayed platelet engraftment after allogeneic hematopoietic stem cell transplantation
Conditions
Interventions
The treatment group:Treat with Hetrombopag Olamine Tablets
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be enrolled in the study: 1.Age>=18 years old, male or female; 2. ECOG score is 0-2; 3.Platelet was not engrafted within 28 days after allogeneic hematopoietic stem cell transplantation (platelet engraftment is defined as platelet count >=20×10^9/L for at least 7 consecutive days without transfusion support); or platelet count20×10^9/L with platelet infusion after primary platelet engraftment posttransplant; 4.Complete donor chimeras; 5.Estimated survival time > 6 months; 6.Obtain written informed consent from the patient.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions cannot be enrolled in this study: 1.Patients who had been treated with TPO-RA within 30 days; 2.Any patients with recurrent malignant tumor; 3.Active infection that is difficult to control; 4.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>2.5x ULN; 5.Total bilirubin>2xULN; 6.According to the standards of the National Institutes of Health, patients diagnosed with grade III to IV acute graft-versus-host disease (GVHD) or severe chronic GVHD; 7.History of severe thrombotic events or known risk factors for thrombosis. Exceptions: subjects whose participation was determined by the investigator to be of greater potential benefit than the potential risk of a thromboembolic event; 8.Heart disease occurred within 6 months before the screening period, such as New York Heart Association (NHYA) Class III/IV congestive heart failure, angina pectoris, myocardial infarction, and arrhythmias requiring treatment; 9.There was prolonged QT syndrome during screening period; 10.Have active hepatitis B or C; 11.Positive antibody against human immunodeficiency virus or treponema pallidum; 12.Those patients unsuitable for inclusion judged by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) after 4 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) of treatment in weeks 2, 6 and 8;Complete response rate (CRR) of treatment in weeks 2, 6, 4 and 8;Partial response rate (PRR) of treatment in weeks 2, 6, 4 and 8;The median dose of hetrombopag when platelet count reaches 20×10^9/L, 50×10^9 /L and 100×10^9 /L for the first time after treatment ;The median time for platelet counts to reach 20×10^9/L, 50×10^9 /L and 100×10^9 /L for the first time after treatment ;Total platelet transfusion during 2, 4, 6 and 8 weeks of treatment;Changes in platelet count after 2, 4, 6, and 8 weeks of treatment;Changes in megakaryocyte levels before treatment and at weeks 4 and 8;Changes in serum ferritin before treatment and at weeks 4 and 8;Changes in platelet antibodies before treatment and at 4 and 8 weeks; | — |
Countries
China
Contacts
Public ContactZhu Xiaoyu
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Outcome results
None listed