Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRenJi Hospital
About this trial
Randomized, controlled, open study to evaluate the efficacy and safety of Hetrombopag in the treatment of chemotherapy-induced thrombocytopenia(CIT) in patients with acute myeloid leukemia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18-70;
Participant with a histologically or cytologically confirmed acute myeloid leukemia in complete remission (PLT≥100×109/L) (except acute promyelocytic leukemia);
Participant who have completed induction therapy and achieved complete remission, have received ≤1 course of intensive consolidation chemotherapy, and will continue to receive intensive consolidation or maintenance chemotherapy;
Intensive chemotherapy after complete remission including: high-dose or medium-dose cytarabine chemotherapy (1-1.5g/m2 q12h×3 days), standard-dose chemotherapy (cytarabine combined with anthracycline/anthraquinones, HHT, pohyllotoxin, etc.);
Disqualifiers
Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
Participant has a history of arterial or venous thrombosis within 6 months before screening (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), or has clinical symptoms and medical history suggestive of thrombophilia;
Participant has a history of severe cardiovascular disease within 6 months before screening, such as congestive heart failure (NYHA class III-IV), arrhythmia known to increase the risk of thromboembolism (atrial fibrillation), post-coronary stent implantation, angioplasty, or coronary artery bypass grafting;
Known human immunodeficiency virus infection,or hepatitis C infection (if hepatitis B surface antigen is positive, or hepatitis B surface antigen is negative but hepatitis B core antibody is positive, HBV-DNA testing is required, if virus replication is suggested, the subject should be excluded);
Trial design
Design model
Parallel
Treatments tested in this trial
Hetrombopag Olamine
DrugThe subjects will initiate treatment with 7.5 mg hetrombopag once a day, starting orally 24 hours after the end of chemotherapy. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts once every two weeks, and maximum dose should not exceed 15 mg daily. Subjects whose platelet count \<25×109/L for 2 weeks, the hetrombopag dose will be increased by 2.5mg. If subjects whose platelet count ≥100×109/L or who had received hetrombopag for 28 days, hetrombopag can be stopped. Hetrombopag Olamine is sponsored by Jiangsu Hengrui Pharmaceuticals Co., Ltd. Emergency treatment: When the platelet count was less than 20×109/L, platelet transfusion was given according to the evaluation of the investigator.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: HetrombopagExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Days that platelet count firstly rebound to 100×109/L
Time frame
Randomization up to 28 daysSecondary outcomes
1
Days that platelet count firstly rebound to 50×109/L
Time frame
Randomization up to 28 days2
The median dose and duration of hetrombopag from starting treatment to platelet count ≥100×109/L
Time frame
Randomization up to 28 days3
The minimum platelet count at the chemotherapy cycle
Time frame
Randomization up to 28 days4
The lasting days of platelet count below 50×109/L at the chemotherapy cycle
Time frame
Randomization up to 28 daysLocations
Sponsors and contacts
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RenJi Hospital
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
Source ClinicalTrials.gov
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