Status:
RECRUITING
Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy
Lead Sponsor:
Instituto de Investigación Marqués de Valdecilla
Conditions:
CMV
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 adop...
Detailed Description
In HAPLO, CMV infection and disease are more frequent than in other type of HSCT, this is related to delayed immune reconstitution after transplant increasing post-transplant infectious complications....
Eligibility Criteria
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 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.
Key Trial Info
Start Date :
March 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04056533
Start Date
March 26 2022
End Date
December 1 2026
Last Update
August 28 2024
Active Locations (1)
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1
Hospital Marques de Valdecilla
Santander, Spain