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

Lymphoma Clinical Trial

Official title:

Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma: An Open, Single-center, Phase II Randomized Controlled Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04797182
• Other study ID #: B2021-034
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Cytarabine Causing Adverse Effects in Therapeutic Use
• Lymphoma
• Thrombocytopenia

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