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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04797182

Enrollment

Registered

2021-03-15

Start date

2021-04-30

Completion date

2023-07-31

Last updated

2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytarabine Causing Adverse Effects in Therapeutic Use, Lymphoma, Thrombocytopenia

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

Interventions

DRUGavatrombopag

avatrombopag,60 mg/d,po

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The incidence of grades III and IV thrombocytopenia	2 years

Secondary

Measure	Time frame
The durations of any grade thrombocytopenia and grades II, III and IV thrombocytopenia	2 years

Countries

China

Contacts

Primary ContactQingqing Cai, MD

caiqq@sysucc.org.cn0086-20-87342823

Backup ContactCai

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026