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Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy

RecruitingPhase 2Ages 18 Years - 80 YearsAllInstituto de Investigación Marqués de Valdecilla
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 lymphocytes or alemtuzuamb, 28 days pre-infusion. * Patients with uncontroled infection defined by fevers and/or inestability and/or infection not resolved. * Persistent fevers 3 days before infusion. * Acute Graft Versus Host Disease (GVHD) grade II-IV. * Relapse or progression after transplant and before infusion day. * 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.
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What it tests

  • CMV CTLs
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Where

1 site
Hospital Marques de Valdecilla
Santander, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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