Avatrombopag to Promote Platelet Engraftment After Allo-HSCT

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

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

Study Overview

• Status: Recruiting
• Conditions: Platelet Disorder
• Intervention / Treatment: Drug: Avatrombopag; Other: Supportive care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yue Han, MD PhD; Phone Number: (0086)51267781856; Email: hanyue@suda.edu.cn
• Study Contact Backup: Name: Depei Wu, MD PhD; Phone Number: (0086)51267781856; Email: drwudepei@163.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: Meng Zhou, MD; Phone Number: +8615606133002; Email: zhoumeng@suda.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University
• Investigators: Principal Investigator: Yue Han, The First Affiliated Hospital of Soochow University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: November 21, 2021
• First Submitted That Met QC Criteria: November 21, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: thrombocytopenia; Avatrombopag; allogenic hematopoietic stem cell transplantation; engraftment
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders
• Other Study ID Numbers: SOOCHOW-HY-2021-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No