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Letermovir for Primary Prophylaxis of Cytomegalovirus Infection After R+HID-HSCT

Primary Purpose

The Incidence of Peripheral Blood CMV Activation and Confirmed Clinically Significant CMV Infection Within 24 Weeks After Transplantation

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Letermovir
Sponsored by
Institute of Hematology & Blood Diseases Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for The Incidence of Peripheral Blood CMV Activation and Confirmed Clinically Significant CMV Infection Within 24 Weeks After Transplantation focused on measuring CMV reactivation, CMV infection, HSCT

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: (1) Underwent HLA-haploidentical donor HSCT and could receive investigational drug within 28 days of transplantation. (2) have documented seropositivity for CMV (recipient CMV IgG seropositivity [R+]) within 1 year before HSCT., plasma CMV-DNA copy number less than the lower limit of detection within 5 days before enrollment (threshold of 1000 copies/ml in our hospital); (3) Age elder than or equal to 18 years; (4) Informed consent may be signed by themselves. (5) HIV negative, HBV, HCV negative; (6) Informed consent must be signed before the start of the study procedures, and informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member. Exclusion Criteria: Subjects who met any of the following criteria were not enrolled in this study: (1) received a previous allogeneic HSCT; (2) has a history of CMV end-organ disease within 6 months prior to enrollment, or has evidence of CMV viremia from a central or local laboratory at any time prior to enrollment; (3) received within 7 days prior to screening or plans to receive during the study any of the following: ganciclovir, valganciclovir, foscarnet sodium, acyclovir (daily oral dose > 3200 mg, or daily intravenous dose > 25 mg/kg), valacyclovir (daily oral dose > 3000 mg), famciclovir (daily oral dose > 1500 mg); (4) received within 30 days prior to screening or plans to receive during the study any of the following: cidofovir, CMV high-titer gamma globulin, any investigational anti-CMV therapy or biological agent; (5) has severe hepatic insufficiency (defined as Child-Pugh Class C; (6) has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 xthe upper limit of normal (ULN) or serum total bilirubin > 2.5 x ULN.(7) has end-stage renal impairment with a creatinine clearance less than 10 mL/min. (8) has both moderate hepatic insufficiency AND moderate renal insufficiency; (9) Uncontrolled infection at enrollment; (10) requires mechanical ventilation or is hemodynamically unstable at the time of enrollment; (11) has documented positive results for human immunodeficiency virus antibody (HIVAb), hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to randomization (12) has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas). (13) Suffering from mental disorders or other conditions and unable to cooperate with the requirements of study treatment and monitoring; 14) unable or unwilling to sign the consent form; 15) pregnant or lactating women; 16) patients with other special conditions assessed as unqualified by the investigator.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    treatment arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    CMV reactivation or clinically significant CMV infection incidence
    The incidence of peripheral blood cytomegalovirus activation and confirmed clinically significant CMV infection

    Secondary Outcome Measures

    Full Information

    First Posted
    June 13, 2023
    Last Updated
    June 13, 2023
    Sponsor
    Institute of Hematology & Blood Diseases Hospital, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05914675
    Brief Title
    Letermovir for Primary Prophylaxis of Cytomegalovirus Infection After R+HID-HSCT
    Official Title
    Efficacy and Safety of Letermovir for Primary Prophylaxis of Cytomegalovirus Infection After HLA-haploidentical Hematopoietic Stem Cell Transplantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institute of Hematology & Blood Diseases Hospital, China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    To evaluate the efficacy and safety of primary prophylaxis of CMV reactivation, clinically significant CMV infection with oral letermovir in Chinese R+ haplo-HSCT patients, as well as treatment-related mortality and all-cause mortality within 24 weeks after transplantation. For enrolled patients, Letermovir would be administered at a dose of 480 mg per day (or 240 mg per day in patients taking cyclosporine). The regimen would start between +7~+14d after transplantation. The total duration of dosing was approximately 100 days or 14 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    The Incidence of Peripheral Blood CMV Activation and Confirmed Clinically Significant CMV Infection Within 24 Weeks After Transplantation
    Keywords
    CMV reactivation, CMV infection, HSCT

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    21 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment arm
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Letermovir
    Intervention Description
    For enrolled patients, Letermovir would be administered at a dose of 480 mg per day (or 240 mg per day in patients taking cyclosporine). The regimen would start between +7~+14d after transplantation. The total duration of dosing was approximately 100 days or 14 weeks.
    Primary Outcome Measure Information:
    Title
    CMV reactivation or clinically significant CMV infection incidence
    Description
    The incidence of peripheral blood cytomegalovirus activation and confirmed clinically significant CMV infection
    Time Frame
    24 weeks after HSCT

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (1) Underwent HLA-haploidentical donor HSCT and could receive investigational drug within 28 days of transplantation. (2) have documented seropositivity for CMV (recipient CMV IgG seropositivity [R+]) within 1 year before HSCT., plasma CMV-DNA copy number less than the lower limit of detection within 5 days before enrollment (threshold of 1000 copies/ml in our hospital); (3) Age elder than or equal to 18 years; (4) Informed consent may be signed by themselves. (5) HIV negative, HBV, HCV negative; (6) Informed consent must be signed before the start of the study procedures, and informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member. Exclusion Criteria: Subjects who met any of the following criteria were not enrolled in this study: (1) received a previous allogeneic HSCT; (2) has a history of CMV end-organ disease within 6 months prior to enrollment, or has evidence of CMV viremia from a central or local laboratory at any time prior to enrollment; (3) received within 7 days prior to screening or plans to receive during the study any of the following: ganciclovir, valganciclovir, foscarnet sodium, acyclovir (daily oral dose > 3200 mg, or daily intravenous dose > 25 mg/kg), valacyclovir (daily oral dose > 3000 mg), famciclovir (daily oral dose > 1500 mg); (4) received within 30 days prior to screening or plans to receive during the study any of the following: cidofovir, CMV high-titer gamma globulin, any investigational anti-CMV therapy or biological agent; (5) has severe hepatic insufficiency (defined as Child-Pugh Class C; (6) has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 xthe upper limit of normal (ULN) or serum total bilirubin > 2.5 x ULN.(7) has end-stage renal impairment with a creatinine clearance less than 10 mL/min. (8) has both moderate hepatic insufficiency AND moderate renal insufficiency; (9) Uncontrolled infection at enrollment; (10) requires mechanical ventilation or is hemodynamically unstable at the time of enrollment; (11) has documented positive results for human immunodeficiency virus antibody (HIVAb), hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to randomization (12) has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas). (13) Suffering from mental disorders or other conditions and unable to cooperate with the requirements of study treatment and monitoring; 14) unable or unwilling to sign the consent form; 15) pregnant or lactating women; 16) patients with other special conditions assessed as unqualified by the investigator.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Letermovir for Primary Prophylaxis of Cytomegalovirus Infection After R+HID-HSCT

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