Back to resultsAvatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma
Primary Purpose
Thrombocytopenia, Cytarabine Causing Adverse Effects in Therapeutic Use, Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
avatrombopag
Sponsored by
About this trial
This is an interventional prevention trial for Thrombocytopenia
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.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
blank control
primary prevention
Arm Description
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.
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
Outcomes
Primary Outcome Measures
The incidence of grades III and IV thrombocytopenia
Secondary Outcome Measures
The durations of any grade thrombocytopenia and grades II, III and IV thrombocytopenia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04797182
Brief Title
Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia, Cytarabine Causing Adverse Effects in Therapeutic Use, Lymphoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
blank control
Arm Type
Experimental
Arm Description
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.
Arm Title
primary prevention
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
avatrombopag
Intervention Description
avatrombopag,60 mg/d,po
Primary Outcome Measure Information:
Title
The incidence of grades III and IV thrombocytopenia
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The durations of any grade thrombocytopenia and grades II, III and IV thrombocytopenia
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Cai, MD
Phone
0086-20-87342823
Email
caiqq@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Cai
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingqing Cai, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingqing Cai, MD
12. IPD Sharing Statement
Learn more about this trial
Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma
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