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

Primary Purpose

Chemotherapy-Induced Thrombocytopenia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hetrombopag Olamine
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-Induced Thrombocytopenia focused on measuring Chemotherapy-Induced Thrombocytopenia, Acute Myeloid Leukemia, Hetrombopag

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Hetrombopag

    Control

    Arm Description

    The study in a 1:1 randomization ratio (36 subjects to experimental group). The treatment group received Herteppa Ethanolamine tablets and platelet transfusion.

    The study in a 1:1 randomization ratio (36 subjects to control group). The control group did not receive other platelet raising therapy except platelet transfusion.

    Outcomes

    Primary Outcome Measures

    Days that platelet count firstly rebound to 100×109/L

    Secondary Outcome Measures

    Days that platelet count firstly rebound to 50×109/L
    The median dose and duration of hetrombopag from starting treatment to platelet count ≥100×109/L
    The minimum platelet count at the chemotherapy cycle
    The lasting days of platelet count below 50×109/L at the chemotherapy cycle
    The lasting days of platelet count below 25×109/L at the chemotherapy cycle
    The number of platelet transfusions at the chemotherapy cycle

    Full Information

    First Posted
    July 5, 2023
    Last Updated
    July 5, 2023
    Sponsor
    RenJi Hospital
    Collaborators
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05944211
    Brief Title
    Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia
    Acronym
    H-CIT-AML
    Official Title
    A Randomized, Controlled Study on the Efficacy and Safety of Hetrombopag in the Treatment of Chemotherapy-induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2026 (Anticipated)
    Study Completion Date
    January 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    RenJi Hospital
    Collaborators
    Jiangsu HengRui Medicine Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy-Induced Thrombocytopenia
    Keywords
    Chemotherapy-Induced Thrombocytopenia, Acute Myeloid Leukemia, Hetrombopag

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hetrombopag
    Arm Type
    Experimental
    Arm Description
    The study in a 1:1 randomization ratio (36 subjects to experimental group). The treatment group received Herteppa Ethanolamine tablets and platelet transfusion.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The study in a 1:1 randomization ratio (36 subjects to control group). The control group did not receive other platelet raising therapy except platelet transfusion.
    Intervention Type
    Drug
    Intervention Name(s)
    Hetrombopag Olamine
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Days that platelet count firstly rebound to 100×109/L
    Time Frame
    Randomization up to 28 days
    Secondary Outcome Measure Information:
    Title
    Days that platelet count firstly rebound to 50×109/L
    Time Frame
    Randomization up to 28 days
    Title
    The median dose and duration of hetrombopag from starting treatment to platelet count ≥100×109/L
    Time Frame
    Randomization up to 28 days
    Title
    The minimum platelet count at the chemotherapy cycle
    Time Frame
    Randomization up to 28 days
    Title
    The lasting days of platelet count below 50×109/L at the chemotherapy cycle
    Time Frame
    Randomization up to 28 days
    Title
    The lasting days of platelet count below 25×109/L at the chemotherapy cycle
    Time Frame
    Randomization up to 28 days
    Title
    The number of platelet transfusions at the chemotherapy cycle
    Time Frame
    Randomization up to 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yi Fang, MD.,Ph.D
    Phone
    86-21-68383144
    Email
    fangyi@renji.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiaofeng Han, MD.,Ph.D
    Organizational Affiliation
    Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Yi Fang, MD.,Ph.D
    Organizational Affiliation
    Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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