Clinical trial NCT05143892: Avatrombopag to Promote Platelet Engraftment After Allo-HSCT
Official title: Study on Avatrombopag for the Promotion of Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Platelet Disorder
Keywords: Avatrombopag
thrombocytopenia
allogenic hematopoietic stem cell transplantation
engraftment
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into avatrombopag group or supportive care group at the ratio of 1:1.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of participants whose PLT reaches ≥ 20*10^9/L without the need for PLT transfusion.
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Percentage of participants whose PLT reaches ≥ 50*10^9/L without the need for PLT transfusion.
timeFrame: up to 4 weeks
measure: 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 )
timeFrame: up to 4 weeks
measure: Volume of PLT transfusion
timeFrame: up to 4 weeks
measure: Hematopoietic reconstruction condition
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The first affiliated hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Yue Han
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou M, Qi J, Gu C, Wang H, Zhang Z, Wu D, Han Y. Avatrombopag for the treatment of thrombocytopenia post hematopoietic stem-cell transplantation. Ther Adv Hematol. 2022 Sep 28;13:20406207221127532. doi: 10.1177/20406207221127532. eCollection 2022.