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

NCT ID: NCT04797182

Last Updated: 2021-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2023-07-31

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

Conditions

Thrombocytopenia; Cytarabine Causing Adverse Effects in Therapeutic Use; Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

blank control

No intervention aiming at preventing thrombocytopenia will be taken after first cycle. Avatrombopag as salvage treatment will be administered to patients suffering from thrombocytopenia with nadir platelet count \< 50 × 109/L at a dose of 60mg/day until there is drug-withdrawal indication.

Group Type: EXPERIMENTAL

avatrombopag

Intervention Type: DRUG

avatrombopag,60 mg/d,po

primary prevention

As the primary prevention of thrombocytopenia induced by cytarabine-based chemotherapy, Avatrombopag will be administered at a dose of 60mg/day on days -3~-1 and 3~9, for a total of 10 doses. On the condition that patients have platelet counts <50 × 10 9 /L before next cycle, Avatrombopag will be administered at a dose of 60mg/day until there is drug-withdrawal indications. Platelet transfusions were administered to patients when the platelet count was less than 10×109 /L.

Drug-withdrawal indications:

PLT ≥ 100×109/L during salvage treatment or platelet count increases by 50×109/L, comparing with baseline level.

When platelet count is higher than 400×109/L during this study, researchers determine whether avatrombopag is discontinued

Group Type: EXPERIMENTAL

avatrombopag

Intervention Type: DRUG

avatrombopag,60 mg/d,po

Interventions

avatrombopag

avatrombopag,60 mg/d,po

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Qingqing Cai

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qingqing Cai, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Qingqing Cai, MD

Role: CONTACT

caiqq@sysucc.org.cn

0086-20-87342823

Cai

Role: CONTACT

Facility Contacts

Qingqing Cai, MD

Role: primary

Other Identifiers

B2021-034

Identifier Type: -

Identifier Source: org_study_id