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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Cytarabine Causing Adverse Effects in Therapeutic Use; Thrombocytopenia; Lymphoma

Treatments: Drug: avatrombopag

Study type: Interventional

Funder types: Other

Identifiers

NCT04797182

B2021-034

Details and patient eligibility

About

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

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

blank control

Experimental group

Description:

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.

Treatment:

Drug: avatrombopag

primary prevention

Experimental group

Description:

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

Treatment:

Drug: avatrombopag