Avatrombopag to Promote Platelet Engraftment After Allo-HSCT

NCT05143892 | Unknown Phase 2 DMC

• 1 other identifier: SOOCHOW-HY-2021-11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Disorder

Keywords

Avatrombopag; thrombocytopenia; allogenic hematopoietic stem cell transplantation; engraftment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  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 )

  up to 4 weeks

• Volume of PLT transfusion

  up to 4 weeks

• Hematopoietic reconstruction condition

  up to 4 weeks

Study Arms (2)

Avatrombopag

EXPERIMENTAL

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

Supportive care

OTHER

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

Other: Supportive care

Interventions

Avatrombopag DRUG

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

Also known as: Doptelet

Avatrombopag

Supportive care OTHER

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

Also known as: support

Supportive care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The first affiliated hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

Related 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.

  PMID: 36185780 BACKGROUND

MeSH Terms

Conditions

Blood Platelet Disorders; Thrombocytopenia

Interventions

avatrombopag; Palliative Care

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yue Han

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Han, MD PhD

CONTACT

(0086)51267781856; hanyue@suda.edu.cn

Depei Wu, MD PhD

CONTACT

(0086)51267781856; drwudepei@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of hematology department

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

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 3, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: November 30, 2023
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)