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Avatrombopag to Promote Platelet Engraftment After Allo-HSCT

Primary Purpose

Platelet Disorder

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Avatrombopag

Supportive care

About this trial

This is an interventional treatment trial for Platelet Disorder focused on measuring Avatrombopag, thrombocytopenia, allogenic hematopoietic stem cell transplantation, engraftment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The first affiliated hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Avatrombopag

Supportive care

Arm Description

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.

Patients in this arm receive same treatment as in the avatrombopag group,except any TPO-RAs or recombinant human thrombopoietin.

Outcomes

Primary Outcome Measures

Percentage of participants whose PLT reaches ≥ 20*10^9/L without the need for PLT transfusion.

Accumulated platelet engraftment ratio

Secondary Outcome Measures

Percentage of participants whose PLT reaches ≥ 50*10^9/L without the need for PLT transfusion.

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 )

time duration of platelet engraftment

Volume of PLT transfusion

Hematopoietic reconstruction condition

absolute neutrophils, hemoglobin

Full Information

NCT ID

NCT05143892

First Posted

November 21, 2021

Last Updated

December 21, 2022

Sponsor

The First Affiliated Hospital of Soochow University

1. Study Identification

Unique Protocol Identification Number

NCT05143892

Brief Title

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

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Platelet Disorder

Keywords

Avatrombopag, thrombocytopenia, allogenic hematopoietic stem cell transplantation, engraftment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Patients will be randomized into avatrombopag group or supportive care group at the ratio of 1:1.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Avatrombopag

Arm Type

Experimental

Arm Description

Arm Title

Supportive care

Arm Type

Other

Arm Description

Patients in this arm receive same treatment as in the avatrombopag group,except any TPO-RAs or recombinant human thrombopoietin.

Intervention Type

Drug

Intervention Name(s)

Avatrombopag

Other Intervention Name(s)

Doptelet

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Supportive care

Other Intervention Name(s)

support

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of participants whose PLT reaches ≥ 20*10^9/L without the need for PLT transfusion.

Description

Accumulated platelet engraftment ratio

Time Frame

up to 4 weeks

Secondary Outcome Measure Information:

Title

Percentage of participants whose PLT reaches ≥ 50*10^9/L without the need for PLT transfusion.

Description

Accumulated complete platelet engraftment ratio

Time Frame

up to 4 weeks

Title

Description

time duration of platelet engraftment

Time Frame

up to 4 weeks

Title

Volume of PLT transfusion

Description

Volume of PLT transfusion

Time Frame

up to 4 weeks

Title

Hematopoietic reconstruction condition

Description

absolute neutrophils, hemoglobin

Time Frame

up to 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yue Han, MD PhD

Phone

(0086)51267781856

hanyue@suda.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Depei Wu, MD PhD

Phone

(0086)51267781856

drwudepei@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yue Han

Organizational Affiliation

The First Affiliated Hospital of Soochow University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The first affiliated hospital of Soochow University

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meng Zhou, MD

Phone

+8615606133002

zhoumeng@suda.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36185780

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.

Results Reference

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Avatrombopag to Promote Platelet Engraftment After Allo-HSCT

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