Actively Recruiting
Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy
Led by Instituto de Investigación Marqués de Valdecilla · Updated on 2024-08-28
15
Participants Needed
1
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients who received an allogeneic stem cell transplant from haploidentical donors (HAPLO).
- Any source of stem cells (peripheral blood or bone marrow).
- Donors must be CMV-seropositive.
- Women must have a negative pregnancy test.
- Signed written informed consent by patient.
- Donors must be HLA haploidentical and CMV-seropositive.
- Donors must be evaluated and suitable.
- Signed written informed consent by donor.
- Donors must not have active infection at leukapheresis.
You will not qualify if you...
- Patients without haploidentical CMV-seropositive donors.
- Patients unable to attend follow-up visits.
- Patients without at least partial hematopoiesis recovery (neutrophil counts >0.5x10^9/L in 3 consecutive post-transplant samples).
- Patients receiving corticosteroids at 0.5 mg/kg/day prednisone dose or equivalent at infusion.
- Patients with ECOG performance status 3 or higher.
- Patients with organic toxicities grade 3 or higher.
- Patients who received ATG, donor lymphocytes, or alemtuzumab within 28 days before infusion.
- Patients with uncontrolled infection, defined by fevers, instability, or unresolved infection.
- Patients with persistent fevers 3 days before infusion.
- Patients with acute graft-versus-host disease grade II to IV.
- Patients with relapse or progression after transplant and before infusion day.
- Patients with CMV reactivation or infection after transplant and before infusion day.
- Patients who do not meet infusion criteria after day 28 post-HAPLO will be considered screening failures and excluded.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Marques de Valdecilla
Santander, Spain
Actively Recruiting
Research Team
M
Miriam Sanchez-Escamilla, MD
CONTACT
L
Lucía Lavín Alconero, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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