Avatrombopag to Promote Platelet Engraftment After Allo-HSCT

Platelet Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05143892
• Other study ID #: SOOCHOW-HY-2021-11
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2022
• Source: The First Affiliated Hospital of Soochow University
• Contact: Yue Han, MD PhD
• Phone: (0086)51267781856
• Email: hanyue[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the efficacy and safety of avatrombopag for the promotion of platelet engraftment after Allo-HSCT.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Platelet Disorders
• Platelet Disorder

Intervention

Drug:
• Avatrombopag
Avatrombopag administered at the described frequency to achieve a target platelet count

Other:
• Supportive care
Supportive care other than TPO-RAs or recombinant human thrombopoietin.

Locations

Country	Name	City	State
China	The first affiliated hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Volume of PLT transfusion	Volume of PLT transfusion	up to 4 weeks
Secondary	Hematopoietic reconstruction condition	absolute neutrophils, hemoglobin	up to 4 weeks