Status:
UNKNOWN
Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Thrombocytopenia
Cytarabine Causing Adverse Effects in Therapeutic Use
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04797182
Start Date
April 1 2021
End Date
July 1 2023
Last Update
March 15 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060