Lymphoid malignancies
Conditions
Interventions
Control group:blood CMV viral load was monitored once weekly, and preemptive antiviral treatment with ganciclovir was initiated as soon as a pre-specified virologic
experimental group:Letermovir
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.Diagnosed with hematological lymphoid malignancies, including Hodgkin lymphoma, non-Hodgkin lymphoma, Burkitt lymphoma, and multiple myeloma; 3.Scheduled to receive immunotherapy and/or autologous stem cell transplantation. 4.CMV-IgG seropositive at screening; 5.Life expectancy >= 6 months; 6.Signed written informed consent;
Exclusion criteria
Exclusion criteria: 1.Active, clinically significant CMV infection or disease within 30 days prior to randomization. 2.History of hypersensitivity to letermovir or any of its excipients. 3.Severe hepatic impairment, defined as Child-Pugh Class C. 4.End-stage renal disease with creatinine clearance 470 msec at screening); E. LVEF < 40%. 7.Treatment with any investigational drug within 28 days prior to enrollment. 8.Receipt of any of the following agents within 28 days prior to enrollment or planned during the study: cidofovir, CMV immunoglobulin, or any investigational CMV antiviral agent/biologic. 9.Prior or current participation in any study involving a CMV vaccine or other investigational CMV agent, or planned participation in such a study during the current study. 10.Pregnant or breastfeeding, or planned pregnancy/breastfeeding within 90 days after the last dose. 11.Documented positive human immunodeficiency virus antibody (HIV-Ab) at any time prior to randomization, or positive hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA within 90 days prior to assignment, or positive hepatitis B surface antigen (HBsAg). Testing for HIV, HBV, or HCV using locally acceptable methods was permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinically significant CMV infection; | — |
Countries
China
Contacts
Public ContactLei Fan
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed