search
Back to results

Hetrombopag in Secondary Prevention of XPO-1 Inhibitor-induced Thrombocytopenia in Lymphoma

Primary Purpose

Chemotherapy-Induced Thrombocytopenia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hetrombopag
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-Induced Thrombocytopenia

Eligibility Criteria

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

Inclusion criteria: Age between 18 and 70 years old, gender is not limited; Lymphoma was confirmed by histopathological or cytological examination; The patient needs to receive Selinexor combined chemotherapy containing XPO-1 inhibitor, which may include R-CHOP, R-gemox, DICE, DHAP, SMILE, etc., but is not limited to the above schemes; Patients who do not routinely undergo preventive platelet elevation therapy after the above treatment can receive salvage therapeutic platelet elevation therapy only when the PLT is < 50×109/L; Patients with the lowest platelet value < 50×109/L after the previous course of treatment. The patient's laboratory examination meets the following criteria: (1) Adequate bone marrow function at Screening: absolute count of blood neutrophils (ANC) ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin (HB) ≥90g/L; (2) Liver function: Without liver metastasis, serum total bilirubin (TBIL) ≤ upper limit of normal (ULN) ×1.5, alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN×3; With liver metastasis, TBIL≤ upper limit of normal (ULN) ×3, ALT, AST≤ULN×5; (3) Kidney function: creatinine (Cr) ≤1.5×ULN; (4) Coagulation function: International standardized ratio (INR) of prothrombin time (PT) ≤ULN×1.5; 7. Able to take oral medications; 8. Patients voluntarily sign informed consent; 9. Survival is expected to be ≥12 weeks at the time of screening, and can be treated with the current chemotherapy regimen for at least 2 cycles; 10. Subjects of reproductive age who agree to use reliable contraceptive methods throughout the study period (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive paste, contraceptive support, abstinence from sex, and insertion of an IUD); Excluding female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or more than 1 year postmenopausal, and male subjects who have undergone bilateral vasectomy or ligation. Exclusion Criteria: Thrombocytopenia caused by non-tumor chemotherapy drugs, including but not limited to hypersplenism, infection, and bleeding (including severe visceral or intracranial bleeding), occurred within 6 months before screening; A history of blood other than lymphoma and chemotherapy-induced thrombocytopenia (CIT), such as acute lymphoblastic leukemia, acute myeloid leukemia, any myeloid malignancy, myelodysplastic syndrome, myeloproliferative diseases, and multiple myeloma; Any history of arterial or venous thrombosis in the 3 months prior to screening; Patients had clinical manifestations of severe bleeding (such as gastrointestinal bleeding, craniocerebral hemorrhage, etc.) 2 weeks before screening, or previous PLT > 400×109/L; The subject has an allergic reaction to hetrombopag or any of its excipients; Serious cardiovascular disease (such as NYHA heart function) in the 6 months prior to screening Score Ⅲ-Ⅳ), arrhythmias known to increase the risk of thromboembolism, such as atrial fibrillation, after coronary stenting, angioplasty, and coronary artery bypass grafting; The subjects participated in other clinical studies of similar platelet enhancing drugs within 30 days prior to screening; As assessed by the investigator, the subject has any concomitant medical history that could impair the subject's safe completion of the study, such as unstable angina pectoris, renal failure on hemodialysis, or active infection requiring intravenous antibiotics; Subjects who are pregnant or breastfeeding, or who cannot use contraception during the trial; Other circumstances in which the investigator considers the subject unsuitable for participation in the study; HIV infected persons;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hetrombopag

    Arm Description

    Hetrombopag 5mg/d

    Outcomes

    Primary Outcome Measures

    The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.
    The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.

    Secondary Outcome Measures

    The minimum and maximum values of median platelets before and after secondary prevention.
    The minimum and maximum values of median platelets before and after secondary prevention.
    The duration of PLT < 75×109 /L, PLT < 50×109 /L and PLT < 25×109 /L before and after chemotherapy;
    The duration of PLT < 75×109 /L, PLT < 50×109 /L and PLT < 25×109 /L before and after chemotherapy;
    The time required for platelet recovery to 100×109/L and 75×109/L;
    The time required for platelet recovery to 100×109/L and 75×109/L;
    The proportion of patients receiving platelet transfusion, the number and amount of transfusion;
    The proportion of patients receiving platelet transfusion, the number and amount of transfusion;
    The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia.
    The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia.

    Full Information

    First Posted
    July 24, 2023
    Last Updated
    September 1, 2023
    Sponsor
    Sun Yat-sen University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05969158
    Brief Title
    Hetrombopag in Secondary Prevention of XPO-1 Inhibitor-induced Thrombocytopenia in Lymphoma
    Official Title
    An Open, Single-center, Phase II Clinical Study of Hetrombopag in Secondary Prevention of XPO-1 Inhibitor Selinexor Combined With Chemotherapy Induced Thrombocytopenia in Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 4, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2025 (Anticipated)
    Study Completion Date
    August 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University

    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
    To explore the efficacy and safety of hetrombopag for secondary prevention of thrombocytopenia caused by XPO-1 inhibitor Selinexor combined with chemotherapy in patients with lymphoma.
    Detailed Description
    To investigate the efficacy and safety of hetrombopag for secondary prevention of thrombocytopenia in patients with lymphoma treated with XPO-1 inhibitor Selinexor combined with chemotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy-Induced Thrombocytopenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hetrombopag
    Arm Type
    Experimental
    Arm Description
    Hetrombopag 5mg/d
    Intervention Type
    Drug
    Intervention Name(s)
    Hetrombopag
    Other Intervention Name(s)
    SHR8735
    Intervention Description
    After screening, patients who were treated with XPO-1 inhibitor Selinexor combined with chemotherapy and developed chemotherapy-related thrombocytopenia (CIT) after treatment and met the secondary prevention criteria were eligible for inclusion criteria. The platelet reduction after the previous chemotherapy was used as the control group: The patients did not routinely receive prophylactic platelet elevation therapy after the previous Selinexor combined chemotherapy, and when PLT < 50×109/L. Platelet reduction after chemotherapy in secondary prevention unit was used as the experimental group: The subjects will initiate treatment with 5 mg hetrombopag once a day, starting orally 5 days before chemotherapy, take it for 5 days (D-5-D-1), and continue taking it orally for 5 days after chemotherapy (D1-D5).
    Primary Outcome Measure Information:
    Title
    The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.
    Description
    The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.
    Time Frame
    Five days before and five days after chemotherapy
    Secondary Outcome Measure Information:
    Title
    The minimum and maximum values of median platelets before and after secondary prevention.
    Description
    The minimum and maximum values of median platelets before and after secondary prevention.
    Time Frame
    2-3 months
    Title
    The duration of PLT < 75×109 /L, PLT < 50×109 /L and PLT < 25×109 /L before and after chemotherapy;
    Description
    The duration of PLT < 75×109 /L, PLT < 50×109 /L and PLT < 25×109 /L before and after chemotherapy;
    Time Frame
    2-3 months
    Title
    The time required for platelet recovery to 100×109/L and 75×109/L;
    Description
    The time required for platelet recovery to 100×109/L and 75×109/L;
    Time Frame
    2-3 months
    Title
    The proportion of patients receiving platelet transfusion, the number and amount of transfusion;
    Description
    The proportion of patients receiving platelet transfusion, the number and amount of transfusion;
    Time Frame
    2-3 months
    Title
    The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia.
    Description
    The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia.
    Time Frame
    2-3 months

    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: Age between 18 and 70 years old, gender is not limited; Lymphoma was confirmed by histopathological or cytological examination; The patient needs to receive Selinexor combined chemotherapy containing XPO-1 inhibitor, which may include R-CHOP, R-gemox, DICE, DHAP, SMILE, etc., but is not limited to the above schemes; Patients who do not routinely undergo preventive platelet elevation therapy after the above treatment can receive salvage therapeutic platelet elevation therapy only when the PLT is < 50×109/L; Patients with the lowest platelet value < 50×109/L after the previous course of treatment. The patient's laboratory examination meets the following criteria: (1) Adequate bone marrow function at Screening: absolute count of blood neutrophils (ANC) ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin (HB) ≥90g/L; (2) Liver function: Without liver metastasis, serum total bilirubin (TBIL) ≤ upper limit of normal (ULN) ×1.5, alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN×3; With liver metastasis, TBIL≤ upper limit of normal (ULN) ×3, ALT, AST≤ULN×5; (3) Kidney function: creatinine (Cr) ≤1.5×ULN; (4) Coagulation function: International standardized ratio (INR) of prothrombin time (PT) ≤ULN×1.5; 7. Able to take oral medications; 8. Patients voluntarily sign informed consent; 9. Survival is expected to be ≥12 weeks at the time of screening, and can be treated with the current chemotherapy regimen for at least 2 cycles; 10. Subjects of reproductive age who agree to use reliable contraceptive methods throughout the study period (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive paste, contraceptive support, abstinence from sex, and insertion of an IUD); Excluding female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or more than 1 year postmenopausal, and male subjects who have undergone bilateral vasectomy or ligation. Exclusion Criteria: Thrombocytopenia caused by non-tumor chemotherapy drugs, including but not limited to hypersplenism, infection, and bleeding (including severe visceral or intracranial bleeding), occurred within 6 months before screening; A history of blood other than lymphoma and chemotherapy-induced thrombocytopenia (CIT), such as acute lymphoblastic leukemia, acute myeloid leukemia, any myeloid malignancy, myelodysplastic syndrome, myeloproliferative diseases, and multiple myeloma; Any history of arterial or venous thrombosis in the 3 months prior to screening; Patients had clinical manifestations of severe bleeding (such as gastrointestinal bleeding, craniocerebral hemorrhage, etc.) 2 weeks before screening, or previous PLT > 400×109/L; The subject has an allergic reaction to hetrombopag or any of its excipients; Serious cardiovascular disease (such as NYHA heart function) in the 6 months prior to screening Score Ⅲ-Ⅳ), arrhythmias known to increase the risk of thromboembolism, such as atrial fibrillation, after coronary stenting, angioplasty, and coronary artery bypass grafting; The subjects participated in other clinical studies of similar platelet enhancing drugs within 30 days prior to screening; As assessed by the investigator, the subject has any concomitant medical history that could impair the subject's safe completion of the study, such as unstable angina pectoris, renal failure on hemodialysis, or active infection requiring intravenous antibiotics; Subjects who are pregnant or breastfeeding, or who cannot use contraception during the trial; Other circumstances in which the investigator considers the subject unsuitable for participation in the study; HIV infected persons;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhiming Li, MD.
    Phone
    +86-13719189172
    Email
    lizhm@sysucc.org.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu Wang, MD.
    Phone
    +86-20-87343765
    Email
    wangyu@sysucc.org.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhiming Li, MD.
    Organizational Affiliation
    Sun Yat-sen University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Hetrombopag in Secondary Prevention of XPO-1 Inhibitor-induced Thrombocytopenia in Lymphoma

    We'll reach out to this number within 24 hrs