- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04797182
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Cai
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
avatrombopag,60 mg/d,po
|
Experimental: 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 |
avatrombopag,60 mg/d,po
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of grades III and IV thrombocytopenia
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The durations of any grade thrombocytopenia and grades II, III and IV thrombocytopenia
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2021-034
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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