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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04797182
Other study ID # B2021-034
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date April 2021
Est. completion date July 2023

Study information

Verified date March 2021
Source Sun Yat-sen University
Contact Qingqing Cai, MD
Phone 0086-20-87342823
Email caiqq@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 46
Est. completion date July 2023
Est. primary completion date April 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
avatrombopag
avatrombopag,60 mg/d,po

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of grades III and IV thrombocytopenia 2 years
Secondary The durations of any grade thrombocytopenia and grades II, III and IV thrombocytopenia 2 years
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