Avatrombopag to Promote Platelet Engraftment After Allo-HSCT

Study Overview
=================
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.

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

Conditions
-----------------
Platelet Disorder

Intervention / Treatment
-----------------
* Drug: Avatrombopag
* Other: Supportive care


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized into avatrombopag group or supportive care group at the ratio of 1:1.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avatrombopag<br>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. | Drug: Avatrombopag<br>* Avatrombopag administered at the described frequency to achieve a target platelet count<br>* Other names: Doptelet;|
| Other: Supportive care<br>Patients in this arm receive same treatment as in the avatrombopag group,except any TPO-RAs or recombinant human thrombopoietin. | Other: Supportive care<br>* Supportive care other than TPO-RAs or recombinant human thrombopoietin.<br>* Other names: support;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants whose PLT reaches ≥ 20*10^9/L without the need for PLT transfusion. | Accumulated platelet engraftment ratio | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants whose PLT reaches ≥ 50*10^9/L without the need for PLT transfusion. | Accumulated complete platelet engraftment ratio | up to 4 weeks | 
| 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 ) | time duration of platelet engraftment | up to 4 weeks | 
| Volume of PLT transfusion | Volume of PLT transfusion | up to 4 weeks | 
| Hematopoietic reconstruction condition | absolute neutrophils, hemoglobin | up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Avatrombopag, thrombocytopenia, allogenic hematopoietic stem cell transplantation, engraftment