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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CMV CTLs
Biological/VaccineThe donor derived cytomegalovirus specific T lymphocytes (CMV-CTL) will be transfused to the patients. The patients will receive CMV-CTL cells when their donors are sero-positive for CMV-DNA 21 days after transplant. The CMV-DNA levels will be monitored weekly for at least 100 days after the HAPLO. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then they may be eligible to receive a CMV specific antiviral drug.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: CMV CTLsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
100-days incidence of CMV infection
Viral load \>200 copies in 1 sample
Time frame
From date of CMV-CTLs infusion to 100 days after transplantSecondary outcomes
1
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.
Time frame
From date of CMV-CTLs infusion to 1 year after transplant2
1-year incidence of CMV disease
CMV disease P.Lungman criteria. CMV as primary cause of death.
Time frame
From date of CMV-CTLs infusion to 1 year after transplantOther outcomes
1
1-year incidence of CMV-CTLs adverse events
Infusion reactions, causes of death, secondary graft failures and graft versus host disease (GVHD).
Time frame
From date of CMV-CTLs infusion to 1 year after transplant2
CMV-CTLs persistence
Expansion of CMV-CTLs detected by flow cytometry.
Time frame
From date of CMV-CTLs infusion to 2 months after infusion3
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.
Time frame
From date of transplant to day 180 post-transplantSponsors and contacts
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Source ClinicalTrials.gov