Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia

Trial Title: Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia

NCT ID: NCT05944211

Condition: Chemotherapy-Induced Thrombocytopenia

Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Thrombocytopenia

Conditions: Keywords:
Chemotherapy-Induced Thrombocytopenia
Acute Myeloid Leukemia
Hetrombopag

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Hetrombopag Olamine
Description: The 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.
Arm group label: Hetrombopag

Summary: 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

Detailed description: This study is a prospective, single center, randomized, controlled and open clinical trial initiated by the researchers to evaluate the efficacy and safety of Hetrombopag in the treatment of thrombocytopenia caused by chemotherapy in acute myeloid leukemia. The study focuses on acute myeloid leukemia patients aged 18-70 who have completed induction chemotherapy and achieved complete remission, and have received ≤ 1 course of intensive therapy for consolidation. Patients were randomly divided into the treatment group and the control group through the random number table by 1:1. The treatment group received Hetrombopag and platelet transfusion, and the control group did not receive other platelet raising therapy except platelet transfusion. The study used the proportion of subjects with effective treatment during the randomized treatment period as the main efficacy indicator. 72 patients are planned to be enrolled, with treatment group and control group=1:1.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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.); - Participant whose Expected survival time ≥3 months, and who can receive at least 2 cycles of intensive chemotherapy; - ECOG performance status <=2; - Participants of childbearing age who agree to use reliable contraceptive methods; - Patients signed the informed consent form and volunteered to participate in this study with good compliance; Exclusion Criteria: - 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); - Abnormal liver function (TBL>3xULN; alanine aminotransferase [ALT] or aspartate aminotransferase [AST]>3xULN); - Abnormal renal function with serum creatinine>1.5xULN or creatinine clearance ≤ 60 ml/min using Cockcroft-Gault estimated creatinine clearance; - Pregnant or lactating women, or those planning to receive/give birth in the near 6 months; - Participant participated in other clinical trials within 3 months before enrollment; - Previous use of thrombopoietin receptor agonist (TPO-RA), recombinant human TPO, recombinant human interleukin-11(rhlL-11) within 1 month before screening; - Received platelet transfusions within 3 days before enrollment; - Patients with known or expected allergy or intolerance to the active ingredient or excipients of hetrombopag; - Inability to understand the nature of the study or failure to obtain informed consent; - The investigator considers that there are any other conditions that may prevent the subject from completing the study or present a significant risk to the subject;

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Start date: July 2023

Completion date: January 2027

Lead sponsor:
Agency: RenJi Hospital
Agency class: Other

Collaborator:
Agency: Jiangsu HengRui Medicine Co., Ltd.
Agency class: Industry

Source: RenJi Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05944211