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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04797182

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Thrombocytopenia Cytarabine Causing Adverse Effects in Therapeutic Use Lymphoma	Drug: avatrombopag	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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.	Drug: avatrombopag 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	Drug: avatrombopag avatrombopag,60 mg/d,po

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.

Drug: avatrombopag

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

Drug: avatrombopag

avatrombopag,60 mg/d,po

Outcome Measures

Primary Outcome Measures

The incidence of grades III and IV thrombocytopenia [2 years]

Secondary Outcome Measures

The durations of any grade thrombocytopenia and grades II, III and IV thrombocytopenia [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Qingqing Cai, MD, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qingqing Cai, Chief physician, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT04797182

Other Study ID Numbers:

B2021-034

First Posted:

Mar 15, 2021

Last Update Posted:

Mar 15, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma

Thrombocytopenia

Study Results

No Results Posted as of Mar 15, 2021