CMV Clinical Trial
— INMUNOCELLOfficial title:
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | March 1, 2026 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 donĀ“t fill infusion criteria, after day 28 post-HAPLO, will be considered screening failures and will be out of the study. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Marques de Valdecilla | Santander |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Marqués de Valdecilla |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 1-year incidence of CMV-CTLs adverse events | Infusion reactions, causes of death, secondary graft failures and graft versus host disease (GVHD). | From date of CMV-CTLs infusion to 1 year after transplant | |
Other | CMV-CTLs persistence | Expansion of CMV-CTLs detected by flow cytometry. | From date of CMV-CTLs infusion to 2 months after infusion | |
Other | Immune reconstitution post-HAPLO | CD3, CD4, CD8, B and NK lymphocyte counts in patient peripheral blood post-transplant (day 30, 60, 90 and 180) detected by flow cytometry. | From date of transplant to day 180 post-transplant | |
Primary | 100-days incidence of CMV infection | Viral load >200 copies in 1 sample | From date of CMV-CTLs infusion to 100 days after transplant | |
Secondary | 1-year incidence of CMV specific antiviral drug use | If viral load >200 copies in 2 samples or >1000 in 1 sample, treatment with valganciclovir will be started.
Time from CMV-CTLs infusion until valganciclovir start and days of valganciclovir. |
From date of CMV-CTLs infusion to 1 year after transplant | |
Secondary | 1-year incidence of CMV disease | CMV disease P.Lungman criteria. CMV as primary cause of death. | From date of CMV-CTLs infusion to 1 year after transplant |
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