Allogeneic stem cells transplantation. Stem cells transplant status
Conditions
Interventions
Intervention 1: Patients in the intervention arm will receive the systemic intravenous infusion of 10 million cells/m2 CMV Specific T-cells after day 14 post-transplants. infusion of CMV-specific T-
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Allogeneic stem cell transplantation recipient Age >=?? CMV seropositive donor
Exclusion criteria
Exclusion criteria: Unrelated donor Participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients With Grades 3-5 of cytotoxic T-cell infusion-related Adverse Events (Version 4.03). Timepoint: Daily during the seven days after the injection. Method of measurement: Physical exam, history and lab tests.;Cytomegalovirus reactivation. Timepoint: Weekly intervals until three months after the T-cell injection. Method of measurement: RT-PCR in the peripheral blood to assess Cytomegalovirus-DNA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Prolonged cytopenia. Timepoint: Daily during the first seven days after the injection and then weekly until one-month after the injection. Method of measurement: Complete peripheral blood cell count.;Acute Graft versus Host Disease. Timepoint: Weekly interval until 100 days post-transplantation. Method of measurement: physical exam, lab test, and biopsy. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohamad Ahmadvand
Tehran University of Medical Sciences
Outcome results
None listed