Cytomegalovirus activation
Conditions
Interventions
Experimental group:Application of intravenous cytomegalovirus human immunoglobulin
Control group:Application of intravenous human immunoglobulin
Sponsors
Soochow Hopes Hematonosis Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-65 years old (including 18 and 65 years old), gender is not limited; 2. Satisfy the following items (1)-(4) at the same time: (1) Subjects with hematological diseases who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), haploid-matched relative donor transplantation (haploidentical) or umbilical cord blood or unrelated volunteer donor transplantation; (2) Donor CMV-IgG positive and recipient CMV-IgG positive; (3) ATG was used in the pretreatment process (except for cord blood transplant recipients); (4) The GVHD prevention program is ATG+CSA+short-range MTX; 3. Assessed by the investigator at the time of screening, the subject has no CMV infection or CMV disease; 4. ECOG physical condition score 0-2 points; 5. Voluntarily participate in this experiment and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Expected survival time =1000 copies/mL during screening; 3. Anti-HCV, anti-HIV or Treponema pallidum antibody positive; 4. Creatinine clearance rate 5 times the upper limit of normal value or total bilirubin > 3 times the upper limit of normal value; 6. Allergic to human immunoglobulin and excipients; 7. Selective IgA deficiency with known anti-IgA antibodies; 8. Severe infections that require intravenous antibiotic treatment and remain uncontrolled; 9. Participated in other clinical studies related to virus prevention or treatment within one month before screening; 10. Patients who are pregnant or breastfeeding, or patients of childbearing age and their spouses cannot guarantee effective contraception during the study medication period and within 90 days after the end of the medication (medically approved birth control such as an IUD, birth control pill or condom); 11. The study may not be completed for other reasons, or the researcher considers it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with CMV reactivation 100 days after transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with CMV disease;Proportion of subjects with CMV reactivation during follow-up after CMV prophylaxis;Proportion of subjects who developed CMV disease during the follow-up period after CMV prophylaxis;CMV-IgG and neutralizing antibody levels at the stage of CMV prevention and treatment;CMV-IgG and neutralizing antibody levels in the follow-up period after CMV prophylaxis;Subject's median CMV reactivation time; | — |
Countries
China
Contacts
Public ContactWu Xiaojin
Soochow Hopes Hematonosis Hospital
Outcome results
None listed