Cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation
Conditions
Interventions
test group 1:Antiviral drugs + 3200U / kg human cytomegalovirus intravenous immunoglobulin (pH4)
test group 2:Antiviral drugs + 1600U / kg human cytomegalovirus intravenous immunoglobulin (pH4)
Control group:Antiviral drugs + 100mg / kg human intravenous immunoglobulin (pH4)
Sponsors
Blood Disease Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years old (including 18,60 years of age) male and female; 2. The blood disease patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), whose transplantation type is haploidentical transplantation; 3. In patients with CMV infection which is specifically referred to CMV-DNA viremia and is accord with any one of the following criterias: (1) Local laboratory tests showed that blood CMV-DNA =1000 copies / ml twice a week (two tests can not be the same day); (2) Local laboratory tests showed a blood CMV-DNA test results = 5000 copies/ml.? 4. Volunteer to participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. ECOG=3; 2. Estimated survival time five times the upper limit of normal or total bilirubin> 50µmol/L; 8. Previously confirmed patients with CMV infection; 9. CMV disease; 10. People allergic to human immunoglobulins, especially those with selective IgA deficiency of anti-IgA antibodies; 11. Patients who are allergic to ganciclovir or foscarnet are known; 12. Patients who have been treated with ganciclovir foscarnet or acyclovir and other drugs that have an anti-CMV effect after CMV infection (except for the low dose aciclovir used to prevent herpes virus infection); 13. Patients with severe (III-IV degree) acute graft-versus-host disease; 14. Patients with post-transplant leukemia relapse or incomplete remission; 15. Patients who participated in other clinical studies within the first three months of screening; 16. Pregnant or lactating female subjects or unable to guarantee effective contraception during the trial; 17. Subjects may not be able to complete the study for other reasons or because the researchers found it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with CMV-DNA <1000 copies / ml twice consecutively within 2 weeks after the onset of CMV infection treatment; | — |
Countries
China
Contacts
Public ContactMingzhe Han
Blood Disease Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed