Eltrombopag for Chemotherapy-induced Thrombocytopenia

Last updated: February 20, 2025
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Overall Status: Active - Recruiting

Phase

2

Condition

Thrombosis

White Cell Disorders

Dysfunctional Uterine Bleeding

Treatment

Eltrombopag

Clinical Study ID

NCT04600960
IIT2020014(Eltrombopag)
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged ≥18 years old, male or female;

  • Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT);Ineffective after repeated treatment with rhTPO or IL-11;

  • Stop radiotherapy or chemotherapy for more than 1 month;

  • Platelet counts <30 ×10^9/L, and bleeding tendency;

  • Estimated survival period ≥ 6 months;

  • People who are willing to sign the informed consent voluntarily and follow theresearch program.

  • Liver and kidney function<1.5×upper limit of normal, qualified for physicalexamination;

  • Subject is practicing an acceptable method of contraception. Women of childbearingpotential must have a negative serum pregnancy test in the whole study;

Exclusion

Exclusion Criteria:

  • Those with uncontrollable primary diseases of important organs, such as extensivemetastasis of malignant tumors, liver failure, heart failure, kidney failure andother diseases;

  • Patients with poor compliance;

  • Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/orhepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA,Cytomegalovirus DNA;

  • Accompanied by extensive and severe bleeding, such as hemoptysis, uppergastrointestinal bleeding, intracranial hemorrhage, etc.

  • There is currently a heart disease requiring treatment or a poorly controlledhypertension judged by the investigator;

  • Patients with thrombotic diseases such as pulmonary embolism, thrombosis, andatherosclerosis;

  • Those who have received allogeneic stem cell transplantation or organtransplantation in the past;

  • Patients with mental disorders who cannot normally obtain informed consent andundergo trials and follow-up;

  • Patients whose toxic symptoms caused by treatment before participating in the trialhave not disappeared;

  • Other serious diseases that may restrict participants from participating in thistrial (such as diabetes; severe heart failure; myocardial obstruction or unstablearrhythmia or unstable angina in the past 6 months; gastric ulcers; mobilityAutoimmune diseases, etc.);

  • Patients with sepsis or patients with other irregular bleeding;

  • Patients taking antiplatelet drugs at the same time;

  • Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionicgonadotropin in urine at screening) and breastfeeding patients;

  • Pre-existing cardiac disease, including congestive heart failure of New York HeartAssociation [NYHA] Grade III/IV, arrhythmia requiring treatment or myocardialinfarction within the last 6 months. No arrhythmia known to increase the risk ofthrombotic events (e.g. atrial fibrillation), or patients with a QT >450msec or QTc > 480 for patients with a Bundle Branch Block;

  • Researchers believe that patients should not participate in the test of any othercondition.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Eltrombopag
Phase: 2
Study Start date:
December 31, 2020
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Chinese Academy of Medical Science and Blood Disease Hospital

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

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