Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy
Trial Parameters
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Brief Summary
Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Recently, strategies based on immunotherapy adoptive cells (IAC) with anti-CMV Cytolitic T Lymphocytes (CMV-CTLs) has been incorporated to prevent or treat CMV after HSCT. The aim to study donor derived CMV-CTLs after haploidentical HSCT (HAPLO) as prophylaxis for CMV infection in transplant patients. CMV-CTLs will be administer at day 21 (+-7 days) post-HAPLO. CMV DNA levels with quantitative PCR will be weekly monitored.
Eligibility Criteria
Inclusion Criteria: * Adult patients who received an alogeneic stem cell transplantation from haploidentical donors (HAPLO). * Any source of stem cells (peripheral blood or bone marrow). * CMV-seropositive donors. * Negative pregnancy test in women. * Signed writen informed consent. * DONORS: 1. HLA haploidentical and CMV-seropositve donors. 2. Donor must be checked and suitable. 3. Signed writen informed consent. 4. Donor without active infection evidence at leukapheresis. Exclusion Criteria: * Patients without haploidentical CMV-seropositive donors. * Patients who are not suitable for follow up visits. CMV-CTLs Infusion Criteria: * Hematopoiesis recovery at least partial (neutrophil counts \>0.5x10\^9/L in at least 3 consecutive samples post-transplant). CMV-CTLs NON-Infusion Criteria: * Patients receiving corticosteroid (dose of 0.5mg/kg/day of prednisone or equivalent) at infusion. * ECOG \> or = 3. * Organic toxicities grade \> or = 3. * Patients who received ATG, donor lymphocyte