Patients with relapsed and refractory cytomegalovirus infection
Conditions
Interventions
trial group:cytomegalovirus specific T cells
Sponsors
Department of Hematology of Anhui Provincial Hospital, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
No minimum to 60 Years
Inclusion criteria
Inclusion criteria: Patients included: Patients with relapsed and refractory CMV infection after UCBT meeting the requirements of this study protocol. Inclusion criteria: 1. Patients with CMV-DNA positive in peripheral blood or diagnosed by cytomegalovirus inclusion body microscopic examination and immunohistochemistry, patients who did not achieve Cr and PR after two weeks of antiviral treatment (see the efficacy indicators section below), or patients who achieved CR and PR through antiviral treatment but relapsed again; 2. They are under 60 years old, regardless of gender or race; 3. Physical condition: ECoG score was 0-2; 4. Cardiac function: left ventricular ejection fraction is greater than or equal to 40%; 5. The expected survival time was more than 12 weeks; 6. Serum creatinine (CR) <=1.5 * ULN (upper limit of normal value), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 * ULN, total bilirubin <= 1.5 * ULN; 7. The patient has self-knowledge ability and can sign the informed consent; the guardian of the child patient agrees to sign the informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria of patients: 1. Patients with grade III -IV acute GVHD or generalized chronic GVHD; 2. Other cellular immunotherapy was performed within two weeks; 3. Pregnant or lactating women; 4. Active HBV or HCV infection; 5. HIV infected persons; Exclusion criteria for donors: 1. Pregnant or lactating women; 2. HBsAg positive, HCV antibody and HIV antibody positive patients; 3. Patients with active infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median survival time; | — |
Countries
China
Contacts
Public ContactJuan Tong
Department of Hematology of Anhui Provincial Hospital, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Outcome results
None listed