Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemother… (NCT04797182) | Clinical Trial Compass
UnknownPhase 2
Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma
China46 participantsStarted 2021-04
Plain-language 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
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 breastfeed…
What they're measuring
1
The incidence of grades III and IV thrombocytopenia