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

NCT04797182 | Unknown Phase 2

• 1 other identifier: B2021-034
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The incidence of grades III and IV thrombocytopenia

  2 years

Secondary Outcomes (1)

• The durations of any grade thrombocytopenia and grades II, III and IV thrombocytopenia

  2 years

Study Arms (2)

blank control

EXPERIMENTAL

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

primary prevention

EXPERIMENTAL

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

Interventions

avatrombopag DRUG

avatrombopag,60 mg/d,po

blank control; primary prevention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Thrombocytopenia; Lymphoma

Interventions

avatrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Qingqing Cai, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingqing Cai, MD

CONTACT

0086-20-87342823; caiqq@sysucc.org.cn

Cai

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 15, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 15, 2021

Record last verified: 2021-03

Locations

CN (1)