Eltrombopag for Chemotherapy-induced Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
To evaluate the efficacy and safety of eltrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；
Patients with poor compliance;
Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
Trial design
Design model
Single group
Treatments tested in this trial
Eltrombopag
DrugThe 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: 50 subjects with chemotherapy-induced thrombocytopeniaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes of the platelet counts after the treatment of eltrombopag
The investigator will assess the changes of the platelet counts after the treatment of eltrombopag from week 1 to week 24.
Time frame
24 weeks2
Incidence of adverse events after the treatment of eltrombopag
The investigator will observe incidence of adverse events after the treatment of eltrombopag, including thrombosis, diarrhea, skin rash, abnormal liver function and so on.
Time frame
24 weeksSecondary outcomes
1
Changes of concentration of TPO in peripheral blood
The investigator will observe the concentration of TPO in peripheral blood before and after the treatment of eltrombopag,if necessary
Time frame
24 weeks2
Changes of concentration of TPO antibodies in peripheral blood
The investigator will observe the concentration of antibodies in peripheral blood ,if necessary
Time frame
24 weeks3
Changes of concentration of anti-c-Mpl antibodies in peripheral blood
The investigator will observe the concentration of antibodies in peripheral blood ,if necessary
Time frame
24 weeks4
Changes of concentration of TPO neutralizing antibodies in peripheral blood
The investigator will observe the concentration of antibodies in peripheral blood ,if necessary
Time frame
24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Tianjin Medical University Second Hospital
Collaborator
Tianjin Third Central Hospital
Collaborator
Tianjin People's Hospital
Collaborator
Henan Cancer Hospital
Collaborator
The Second Affiliated Hospital of Kunming Medical University
Collaborator
Source ClinicalTrials.gov