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Secondary Prophylaxis of CMV Infection Using Letermovir After HID-HSCT

Primary Purpose

To Evaluate the Efficacy and Safety of Secondary Prophylaxis of CMV Reactivation

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Letermovir for secondary prophylaxis
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 To Evaluate the Efficacy and Safety of Secondary Prophylaxis of CMV Reactivation

Eligibility Criteria

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

Inclusion Criteria: - (1) Underwent HLA-haploidentical donor HSCT, after at least 1 treated CMV episode since transplant in patients who did not receive primary prophylaxis. (2) Age elder than or equal to 18 years; (3) Informed consent may be signed by themselves. (4) HIV negative, HBV, HCV negative; (5) 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: (1) received a previous allogeneic HSCT; (2) has evidence of CMV viremia from a central or local laboratory, or CMV end-organ disease within one week prior to enrollment; (3) received within 30 days prior to screening or plans to receive during the study any of the following: cidofovir, or any investigational anti-CMV therapy or biological agent; (4) has severe hepatic insufficiency (defined as Child-Pugh Class C; (5) has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 xthe upper limit of normal (ULN) or serum total bilirubin > 2.5 x ULN. (6) has end-stage renal impairment with a creatinine clearance less than 10 mL/min. (7) has both moderate hepatic insufficiency AND moderate renal insufficiency; (8) Uncontrolled infection at enrollment; (9) requires mechanical ventilation or is hemodynamically unstable at the time of enrollment; (10) 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 enrollments; (11) 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). (12) Suffering from mental disorders or other conditions and unable to cooperate with the requirements of study treatment and monitoring; (13) unable or unwilling to sign the consent form; (14) pregnant or lactating women; (15) 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

    Incidence of CMV reactivation and CMV infection
    The incidence of peripheral blood cytomegalovirus activation and confirmed clinically significant CMV infection occurred within 1 year after treatment; if the patient terminated letemovir treatment for any reason after treatment, or clinical data loss occurred within 1 year, it was also included in the primary endpoint event.

    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
    NCT05914701
    Brief Title
    Secondary Prophylaxis of CMV Infection Using Letermovir After HID-HSCT
    Official Title
    Efficacy and Safety of Letermovir for Secondary 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 secondary prophylaxis of CMV reactivation, clinically significant CMV infection with oral letermovir in Chinese haplo-HSCT patients, as well as treatment-related mortality, all-cause mortality and QoL 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 duration of dosing was approximately 120 days or 16 weeks. Or physicians could adjust regimen duration according to the CMV infection risk factors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    To Evaluate the Efficacy and Safety of Secondary Prophylaxis of CMV Reactivation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    31 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment arm
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Letermovir for secondary prophylaxis
    Other Intervention Name(s)
    secondary prophylaxis of CMV reactivation
    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 duration of dosing was approximately 120 days or 16 weeks. Or physicians could adjust regimen duration according to the CMV infection risk factors.
    Primary Outcome Measure Information:
    Title
    Incidence of CMV reactivation and CMV infection
    Description
    The incidence of peripheral blood cytomegalovirus activation and confirmed clinically significant CMV infection occurred within 1 year after treatment; if the patient terminated letemovir treatment for any reason after treatment, or clinical data loss occurred within 1 year, it was also included in the primary endpoint event.
    Time Frame
    1 year after letermovir administration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - (1) Underwent HLA-haploidentical donor HSCT, after at least 1 treated CMV episode since transplant in patients who did not receive primary prophylaxis. (2) Age elder than or equal to 18 years; (3) Informed consent may be signed by themselves. (4) HIV negative, HBV, HCV negative; (5) 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: (1) received a previous allogeneic HSCT; (2) has evidence of CMV viremia from a central or local laboratory, or CMV end-organ disease within one week prior to enrollment; (3) received within 30 days prior to screening or plans to receive during the study any of the following: cidofovir, or any investigational anti-CMV therapy or biological agent; (4) has severe hepatic insufficiency (defined as Child-Pugh Class C; (5) has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 xthe upper limit of normal (ULN) or serum total bilirubin > 2.5 x ULN. (6) has end-stage renal impairment with a creatinine clearance less than 10 mL/min. (7) has both moderate hepatic insufficiency AND moderate renal insufficiency; (8) Uncontrolled infection at enrollment; (9) requires mechanical ventilation or is hemodynamically unstable at the time of enrollment; (10) 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 enrollments; (11) 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). (12) Suffering from mental disorders or other conditions and unable to cooperate with the requirements of study treatment and monitoring; (13) unable or unwilling to sign the consent form; (14) pregnant or lactating women; (15) patients with other special conditions assessed as unqualified by the investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Secondary Prophylaxis of CMV Infection Using Letermovir After HID-HSCT

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