NCT04600960

Eltrombopag for Chemotherapy-induced Thrombocytopenia

Eltrombopag for Chemotherapy-induced Thrombocytopenia: a Prospective Multi-center One-arm Study in Solid Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of eltrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors

Detailed description

This is a single-arm study to evaluate the safety and efficacy of eltrombopag to treat chemotherapy-induced thrombocytopenia（CIT）. These subjects have been treated with recombinant human thrombopoietin（rhTPO） or interleukin 11（IL-11） before, the platelets can rise to normal or reach the effective standard, but after the re-application, the effective standard is not reached, or the effective standard is still not reached after the rhTPO 300U/kg/d treatment for 14 days. The investigator will assess the changes of the platelet counts after the treatment of eltrombopag from week 1 to week 24, and observe incidence of adverse events during the treatment of eltrombopag.The investigator will complete the 4 weeks safety visits（once a week），if the subjects end or withdraw from the clinical trial. Patients with chemotherapy-induced thrombocytopenia who had the same inclusion and exclusion criteria in the same period or in the past will be compared with the efficacy and safety of supportive treatment in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of eltrombopag treatment.

Conditions

• Chemotherapy-induced Thrombocytopenia
• Eltrombopag

Interventions

Type	Name	Description
DRUG	Eltrombopag	The subjects will initiate treatment with 75 mg eltrombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts, and maximum dose should not exceed 75 mg daily. Subjects whose platelet count ≤100×109/L，the eltrombopag dose will maintain. If platelet count \>100×109/L for 2 weeks, the subjects need to reduce the dose of eltrombopag to the next lower dose or lower frequency. If subjects whose platelet count exceeds 100×109/L for 4 weeks，already have reduced the dose of eltrombopag to 25mg once every other day during the treatment period, eltrombopag can be stopped for observation, until platelet counts fall below 100×109/L. If the subjects do not need further chemotherapy or radiotherapy, the subjects can taper off eltrombopag if the platelet is greater than 50×109/L.

Timeline

• Start date: 2020-12-31
• Primary completion: 2025-03-31
• Completion: 2025-12-31
• First posted: 2020-10-23
• Last updated: 2025-02-24

Locations

1 site across 1 country: China