Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy
ConditionCMV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstituto de Investigación Marqués de Valdecilla
About this trial
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
Qualifiers
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.
Disqualifiers
Patients without haploidentical CMV-seropositive donors.
Patients who are not suitable for follow up visits.
Hematopoiesis recovery at least partial (neutrophil counts >0.5x10^9/L in at least 3 consecutive samples post-transplant).
Patients receiving corticosteroid (dose of 0.5mg/kg/day of prednisone or equivalent) at infusion.
Trial design
Treatments tested in this trial
- CMV CTLs
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov