Platelet Disorder
Conditions
Keywords
Avatrombopag, thrombocytopenia, allogenic hematopoietic stem cell transplantation, engraftment
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.
Interventions
DRUGAvatrombopag
Avatrombopag administered at the described frequency to achieve a target platelet count
OTHERSupportive care
Supportive care other than TPO-RAs or recombinant human thrombopoietin.
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized into avatrombopag group or supportive care group at the ratio of 1:1.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYue Han, MD PhD
Backup ContactDepei Wu, MD PhD
Outcome results
None listed