Avatrombopag to Promote Platelet Engraftment After Allo-HSCT

Soochow University

Status and phase: Enrolling; Phase 2

Conditions: Platelet Disorder

Treatments: Drug: Avatrombopag; Other: Supportive care

Study type: Interventional

Funder types: Other

Identifiers

NCT05143892

SOOCHOW-HY-2021-11

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Avatrombopag

Experimental group

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.

Treatment:

Drug: Avatrombopag

Supportive care

Other group

Description:

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

Treatment:

Other: Supportive care