Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma

Study Overview
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Brief Summary
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This phase 2 trial studies the efficacy and safety of Avatrombopag for the primary prevention of thrombocytopenia induced by cytarabine-based chemotherapy in patients with lymphoma

Official Title
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Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma: An Open, Single-center, Phase II Randomized Controlled Clinical Study

Conditions
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Thrombocytopenia, Cytarabine Causing Adverse Effects in Therapeutic Use, Lymphoma

Intervention / Treatment
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* Drug: avatrombopag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed lymphoma; Patients are scheduled to receive cytarabine-based chemotherapy including Ara-C at dose of 4g/m2. Eastern Cooperative Oncology Group (ECOG) of 0-1; Proper functioning of the major organs: 1) The absolute value of neutrophils (>1.5×10^9/L); platelet count (> 100×10^9/L); Hemoglobin (> 90 g/L); 2) Serum total bilirubin < 1.5 times ULN; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) < 3 times ULN;3) Serum creatinine <1.5 times Upper Limit Normal (ULN) ; 4) Coagulation function: International Normalized Ratio (INR), Prothrombin Time (PT)< 1.5 times ULN Able to use oral drugs Patients volunteer to sign an informed consent Life expectancy > 3 months; Contraceptives are used Exclusion Criteria: Thrombocytopenia unrelated to chemotherapy during six months before screening, including but not limited to hypersplenism, infection and hemorrhage. In addtion to CIT caused by lymphoma and chemotherapy,patients also suffer from other blood diseases including ALL, AML, myeloid neoplasms, MDS, myeloproliferative disorders, MM; A thrombosis of a coronary artery or vein developed during three months before screening; Haemorrhage with severe clinical symptoms, such as gastrointestinal and cerebral hemorrhage; Platelet transfusion during two days before randomization; Allergic to avatrombopag; Participation in any other research about novel agents or devices; Pregnant or breastfeeding women; Researchers consider it unsuitable for patients to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blank control<br>No intervention aiming at preventing thrombocytopenia will be taken after first cycle. Avatrombopag as salvage treatment will be administered to patients suffering from thrombocytopenia with nadir platelet count < 50 × 109/L at a dose of 60mg/day until there is drug-withdrawal indication. | Drug: avatrombopag<br>* avatrombopag,60 mg/d,po<br>|
| Experimental: primary prevention<br>As the primary prevention of thrombocytopenia induced by cytarabine-based chemotherapy, Avatrombopag will be administered at a dose of 60mg/day on days -3 -1 and 3 9, for a total of 10 doses. On the condition that patients have platelet counts <50 × 10 9 /L before next cycle, Avatrombopag will be administered at a dose of 60mg/day until there is drug-withdrawal indications. Platelet transfusions were administered to patients when the platelet count was less than 10×109 /L. Drug-withdrawal indications: PLT ≥ 100×109/L during salvage treatment or platelet count increases by 50×109/L, comparing with baseline level. When platelet count is higher than 400×109/L during this study, researchers determine whether avatrombopag is discontinued | Drug: avatrombopag<br>* avatrombopag,60 mg/d,po<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of grades III and IV thrombocytopenia |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The durations of any grade thrombocytopenia and grades II, III and IV thrombocytopenia |  | 2 years |