Aplastic anemia
Conditions
Interventions
Experimental group:Oral letermovir
Control group:Standard therapy of IST combined with TPO-RA for SAA
Sponsors
Suzhou Hongci Blood Disease Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 12-70 years old, regardless of gender; 2. SAA patients receiving IST combined with TPO-RA; 3. ECOG score 0-3; 4. The patient or his/her guardian must be able to understand and be willing to participate in the study and sign the informed consent form; 5. Total bilirubin <= 10 times the upper limit of normal and serum creatinine <= 1.5 times the upper limit of normal at the start of the study; 6. negative for serum human immunodeficiency virus (HIV) antigen or antibody. Hepatitis C virus (HCV) antibody negative, or HCV antibody positive but HCV-RNA negative; 8. Hepatitis B virus (HBV) surface antigen and core antibody are both negative. If any one of them is positive, the quantity of HBV-DNA in peripheral blood should be < 1 * 10E2IU/ml; 9. CMV-DNA is negative.
Exclusion criteria
Exclusion criteria: 1. Hepatic and renal dysfunction: creatinine levels >= 177 umol/L (1.5 mg/DL), transaminase and bilirubin levels significantly increased (3 times or more above the upper limit of normal); 2. Clinically uncontrolled active infections (including bacterial, viral or fungal infections), but patients under effective drug therapy are not excluded; 3. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis, viral infection, active hepatitis B/C;when HBsAg and HBcAg are positive, HBV-DNA positive patients should be excluded, and negative patients can enter this clinical trial;HCV-RNA positive hepatitis C patients are excluded). Patients with chronic hepatitis B and albumin level = 10.4. 4.Critically ill or complicated by severe liver, kidney, heart, nerve, lung, infectious or metabolic diseases, the patient may not be able to tolerate the treatment plan or may die within 7-10 days. 5. Pregnant or lactating women. 6. Suffering from mental disorders and unable to cooperate with the requirements of research, treatment and monitoring. 7. There was a history of CMV end-organ disease 6 months before enrollment; 8. Received or plan to receive any of the following drugs during the study within 7 days prior to enrollment: ganciclovir, valganciclovir, foscarnet, acyclovir (dose > 3200 mgpo/day or > 25 mg/kgiv/day), valaciclovir (dose > 3000 mgpo/day), famcicloir (dose > 1500 mgpo per day); 9. Any of the following treatments received or planned to be received during the study period: cidofovir, CMV immunoglobulin, any investigational CMV antiviral drug/biologic therapy within 30 days prior to enrollment; 10.Allergic reaction to the drug used in this study. 11. Active solid malignancy; 12. Those who are conducting clinical trials of other drugs. 13. Expected to donate eggs or sperm from the time informed consent is signed until 90 days after the last dose of study treatment; 14. The patient was unable to understand or follow the study protocol. 15. The investigator determines that the patient has other reasons for not being eligible to participate in the study, or that participation in the study would pose a significant risk to the patient.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Incidence of CMV infection within 24 weeks after treatment.;Incidence of CMV end-organ disease within 14 and 24 weeks after treatment;Initiation time and treatment course of preemptive therapy for CMV infection;Side effects of letermovir in combination with IST and TPO-RA;CR rates at 14 and 24 weeks of IST plus TPO-RA;All-cause mortality;OR;OS;FFS; | — |
Primary
| Measure | Time frame |
|---|---|
| Incidence of CMV infection within 14 weeks after treatment.; | — |
Countries
China
Contacts
Public ContactLimin Liu
Suzhou Hongci Blood Disease Hospital
Outcome results
None listed