Secondary Prophylaxis of CMV Infection Using Letermovir After HID-HSCT

Efficacy and Safety of Letermovir for Secondary Prophylaxis of Cytomegalovirus Infection After HLA-haploidentical Hematopoietic Stem Cell Transplantation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: To Evaluate the Efficacy and Safety of Secondary Prophylaxis of CMV Reactivation
• Intervention / Treatment: Drug: Letermovir for secondary prophylaxis

• Study Type: Interventional
• Enrollment (Estimated): 31
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment arm	Drug: Letermovir for secondary prophylaxis; 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.; Other Names: secondary prophylaxis of CMV reactivation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year after letermovir administration

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Letermovir
• Other Study ID Numbers: IIT-CMV-SP-01

Drug and device information, study documents

• 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