Study on Avatrombopag for the Promotion of Platelet Engraftment After Allo-HSCT
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of avatrombopag in the treatment of thrombocytopenia after Allo-HSCT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Detailed Description
Patients with thrombocytopenia after allogenic hematopoietic stem cell transplantation (Allo-HSCT) who meet Eligibility Criteria were randomly assigned into the avatrombopag group and the rhTPO treatment group(standard group) with 1:1 ratio. The study is divided into two stages, including 4-weeks' core study and 4-weeks' extended study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Avatrombopag In the 4-weeks' core study,the initial dose of avatrombopag is 20 mg/d. If the patient's PLT count remains less than 20*109/L after one week, the maximum dose was increased to 40 mg/d. Avatrombopag will be taken orally with food;in the 4-weeks' extended study,participants in the avatrombopag group who does not meet the withdrawal indication can be enrolled in the extended study and continue the avatrombopag treatment with a maximum dose of 60 mg/d. |
Drug: Avatrombopag
Participants are randomly assigned into the avatrombopag group and the rhTPO treatment group(standard group) with 1:1 ratio. The initial dose of avatrombopag is 20 mg/d. If the patient's PLT count remains less than 20*109/L after one week, the maximum dose was increased to 40 mg/d. Avatrombopag will be taken orally with food.
Other Names:
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| Active Comparator: rhTPO In the 4-weeks' core study,the rhTPO will be subcutaneously injected with dosage of 300 U/kg/d. |
Drug: rhTPO
Participants are randomly assigned into the avatrombopag group and the rhTPO treatment group(standard group) with 1:1 ratio.The rhTPO will be subcutaneously injected with dosage of 300 U/kg/d;
Other Names:
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Outcome Measures
Primary Outcome Measures
- Percentage of participants whose PLT reaches ≥ 20*109/L without the need for PLT transfusion. [up to 4 weeks]
Percentage of participants whose PLT reaches ≥ 20*109/L without the need for PLT transfusion for consecutive 7 days during core study.
Secondary Outcome Measures
- Percentage of participants whose PLT reaches ≥ 20*109/L without the need for PLT transfusion. [up to 4 weeks]
Percentage of participants whose PLT reaches ≥ 20*109/L without the need for PLT transfusion for consecutive 7 days during extended study.
- Percentage of participants without PLT response [up to 8 weeks]
Percentage of participants without PLT response in the standard group but with PLT reconstruction after receiving avatrombopag.
- Percentage of participants with PLT≥ 50*109/L without the need of PLT transfusion [up to 8 weeks]
Percentage of participants with PLT≥ 50*109/L without the need of PLT transfusion for consecutive 7 days during the core and extended study.
- The time to achieve PLT ≥ 20*109/L without the need of PLT transfusion [up to 8 weeks]
The time to achieve PLT ≥ 20*109/L without the need of PLT transfusion for consecutive 7 days in both group.
- Proportion of participants achieving platelet reconstitution [after 4 weeks]
Proportion of participants achieving platelet reconstitution after 4 weeks of drug withdrawal.
- Volume of PLT transfusion [up to 8 weeks]
Volume of PLT transfusion
- Hematopoietic reconstruction condition [up to 8 weeks]
absolute neutrophils, hemoglobin
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, aged between 18-60 years;
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PLT has not been reconstructed 14 days after Allo-HSCT (PLT reconstruction was defined as the status of peripheral PLT count > 20*109/L for consecutive 7 days without the need for PLT transfusion);
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Expected survival time > 3 months;
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ECOG performance status 0-2;
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Agree to receive the treatment of avatrombopag after Allo-HSCT and must sign the informed consent form.
Exclusion Criteria:
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Pregnant or lactating;
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With severe and uncontrollable infection;
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With graft-versus-host disease (GVHD) with steroid resistance;
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With thrombotic microangiopathy; With active thromboembolism requiring anticoagulation
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With detected disease recurrence due to chimerism by flow cytometry;
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With chronic active hepatitis B and C virus infection;
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With secondary or multiple transplantation, or multiple organ transplantation;
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With severe heart disease, lung disease, diabetes and metabolic diseases;
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HIV positive;
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With a history of PLT dysfunction or bleeding disorders
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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);
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With progressive solid tumor;
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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;
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With any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study;
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With treatment of thrombopoietin receptor agonist (TPO-RA) one month before enrollment;
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Deemed unsuitable for enrollment by the investigator.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The First Affiliated Hospital of Soochow University
Investigators
- Principal Investigator: Yue Han, The First Affiliated Hospital of Soochow University
Study Documents (Full-Text)
More Information
Publications
None provided.- SOOCHOW-HY-2021-11