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

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

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.