cytomegalovirus infection
Conditions
Interventions
Test group:Lettermovir prevention
Sponsors
The First Affiliated Hospital Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1: Patients with CMV seropositivity 2: Patients who plan to undergo allogeneic hematopoietic stem cell transplantation or before neutrophil implantation after allogeneic hematopoietic stem cell transplantation 3: Subject age = 18 years old 4: Patients with baseline CMV-DNA negative before enrollment 5: Being able to comply with the research visit schedule, understand and comply with all experimental protocol requirements, sign an informed consent form, and voluntarily participate in the study 6: No desire to conceive within 90 days from the date of consent until the last study treatment dose administration.
Exclusion criteria
Exclusion criteria: 1) Patients who have received allogeneic hematopoietic stem cell transplantation in the past; 2) Patients who have allergic reactions to the drugs or similar drugs used in this study; 3) Pregnancy or breastfeeding within 90 days after the last dose is being administered or planned; 4) Received any investigational drug treatment within the first 28 days; 5) Evidence of CMV viremia at any time prior to enrollment; 6) 6 months prior to enrollment, there was a history of CMV terminal organ disease; 7) Suspected or known to be allergic to active or non active ingredients in the formulation of Letymol; 8) Received or planned to receive any of the following drugs within 7 days prior to enrollment: ganciclovir, valganciclovir, phosphonic acid, acyclovir (dose>3200 mg PO/day or>25 mg/kg IV/day), valciclovir (dose>3000 mg PO/day), famciclovir (dose>1500 mg PO/day); 9) Received or planned to receive any of the following treatments within 30 days prior to enrollment: Cedovir, CMV immunoglobulin, or any experimental CMV antiviral drug/biological therapy during the study period; 10) Severe liver dysfunction (defined as Child Pugh C-grade); 11) End stage renal disease, creatinine clearance rate<10 mL/min; 12) Patients with moderate liver dysfunction (Child Pugh B grade) and moderate or severe renal dysfunction (creatinine clearance rate<50 mL/min); 13) Hemodynamic instability during mechanical ventilation or enrollment; 14) Within 90 days prior to enrollment, evidence of human immunodeficiency virus antibody (HIV-Ab), active hepatitis C virus infection (detectable HCV RNA), or positive hepatitis B surface antigen (HBsAg) was recorded; 15) Suffering from active solid malignant tumors, except for local basal cell or squamous cell skin cancer or diseases under treatment (such as lymphoma); 16) Expect to donate eggs or sperm within 90 days from the signing of the informed consent form to the last administration of the study treatment; 17)Currently participating in or have participated in studies using unapproved research compounds or devices within 28 days prior to the first administration of this study, or have a 5-fold half-life of research compounds (excluding monoclonal antibodies), compared to the elder shall prevail. Subjects who have previously received monoclonal antibody therapy are eligible to participate in this study after a 28 day washout period; (Note: It is allowed to use experimental chemotherapy regimens involving approved drugs, experimental antibacterial regimens involving approved antibacterial/antifungal/antiviral drugs, experimental radiotherapy studies, or other observational studies) 18) Has participated in or is currently participating in any research involving the administration of CMV vaccines or other CMV trials, or plans to participate in research on CMV vaccines or other CMV trial drugs during this study; 19) At the time of signing the informed consent form, they were entertainment or illegal drug users, or had a recent history of drug or alcohol abuse or dependence (within the past year); 20) There is any past or current evidence of any illness, treatment, laboratory test abnormalities, or other circumstances that may confuse the study results, interfere with the participant's participation throughout the entire study period, or lead to the researcher's judgment that there will be excessive risk, resulting in participation in this study not being in the best interest of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically significant incidence of CMV infection within 14 weeks after transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically significant incidence of CMV infection until the 24th week after transplantation;The incidence of CMV terminal organ disease at 14 and 24 weeks after transplantation;Until the 14th and 24th weeks after transplantation, the time and treatment course for initiating preemptive treatment due to CMV infection;;All cause mortality rate and non recurrent mortality rate until the 14th week and 24th week after transplantation;; | — |
Countries
China
Contacts
Public ContactTong hongyan
The First Affiliated Hospital Zhejiang University
Outcome results
None listed