Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy
Key facts
- Where
- A Coruña, Madrid, Oviedo, Palma, Salamanca, and Santander, SpainSee the 6 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04056533, who can take part
Where in Spain
- Complejo Hospitalario Universitario A CoruñaA Coruña, SpainNot yet recruiting
- Hospital Universitario Ramón y CajalMadrid, SpainNot yet recruiting
- Hospital Universitario Central De AsturiasOviedo, SpainNot yet recruiting
- University Hospital Son EspasesPalma, SpainNot yet recruiting
- Hospital Universitario De SalamancaSalamanca, SpainNot yet recruiting
- Hospital Universitario Marqués de ValdecillaSantander, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Instituto de Investigación Marqués de Valdecilla
- Trial code
- NCT04056533EU 2024-520020-28-00
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
Anti-CMV Pilot Clinical Trial: Prophylaxis of Cytomegalovirus Infection in Haploidentical Transplatation of Hematopoietic Progenitors With Adoptive Cell Inmunotherapy
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.
Inclusion: 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:; HLA haploidentical and CMV-seropositve donors; Donor must be checked and suitable; Signed writen informed consent; Donor without active infection evidence at leukapheresis.
Exclusion: Patients receiving corticosteroid (dose of 0.5mg/kg/day of prednisone or equivalent) at infusion; Persistent fevers 3 days before infusion; Relapse or progression after transplant and before infusion day; Patients with uncontroled infection defined by fevers and/or inestability and/or infection not resolved; Acute Graft Versus Host Disease (GVHD) grade II-IV; CMV reactivation/infection after transplant and before infusion day; Patients who don´t fill infusion criteria, after day 28 post-HAPLO, will be considered screening failures and will be out of the study; 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 who received ATG, donor lymphocytes or alemtuzuamb, 28 days pre-infusion; Patients without haploidentical CMV-seropositive donors; Patients who are not suitable for follow up visits; CMV-CTLs Infusion Criteria:; ECOG > or = 3; Organic toxicities grade > or = 3.