Actively Recruiting
Prophylaxis of Cytomegalovirus Infection in Haploidentical Hematopoietic Stem Cell Transplantation Using Donor-Derived Adoptive Cell Immunotherapy
Led by Instituto de Investigación Marqués de Valdecilla · Updated on 2024-08-28
15
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cytomegalovirus (CMV) infection is a significant cause of illness and death in patients who receive allogeneic hematopoietic stem cell transplants, especially from haploidentical donors (HAPLO). This study evaluates the use of donor-derived CMV-specific cytotoxic T lymphocytes (CMV-CTLs) given as a preventive treatment to reduce CMV infection after HAPLO transplantation. The trial is a Phase 2 clinical study focusing on the safety and effectiveness of this immunotherapy approach in transplant patients. Patients eligible for this study will receive an infusion of donor-derived CMV-CTLs around 21 days (plus or minus 7 days) after their HAPLO transplant if their donors are CMV-seropositive. The CMV-CTLs are obtained from donor leukapheresis and processed to isolate the specific cells, which are then given intravenously to the patient at a dose of 1x10^5 cells per kilogram. After the initial infusion, patients will be monitored weekly for CMV DNA levels using quantitative PCR for at least 100 days. If a patient develops a viral infection after the CMV-CTL infusion, they may receive standard anti-CMV antiviral drugs. During the study, participants will undergo weekly blood tests to track CMV viral load for up to 100 days after transplant. The primary outcome is the incidence of CMV infection within 100 days post-infusion. Secondary outcomes include the use of CMV antiviral drugs and occurrence of CMV disease within one year after transplant. Safety and follow-up assessments will continue for up to one year to evaluate the long-term effects of the treatment. Overall participation will involve careful monitoring and regular clinical visits to ensure patient safety and gather study data.
CONDITIONS
Brief 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 transplantation from haploidentical donors (HAPLO).
- Any source of stem cells (peripheral blood or bone marrow).
- CMV-seropositive donors.
- Negative pregnancy test in women.
- Signed written informed consent.
- Donors must be HLA haploidentical, CMV-seropositive, checked as suitable, without active infection at leukapheresis, and have signed written informed consent.
You will not qualify if you...
- Patients without haploidentical CMV-seropositive donors.
- Patients not suitable for follow-up visits.
- Patients receiving corticosteroids at doses of 0.5 mg/kg/day prednisone or equivalent at infusion.
- ECOG performance status of 3 or higher.
- Organic toxicities grade 3 or higher.
- Patients who received ATG, donor lymphocytes, or alemtuzumab within 28 days before infusion.
- Patients with uncontrolled infection or persistent fevers within 3 days before infusion.
- Acute Graft Versus Host Disease grade II-IV.
- Relapse or progression after transplant and before infusion day.
- CMV reactivation or infection after transplant and before infusion day.
- Patients who do not meet hematopoiesis recovery criteria (neutrophil counts >0.5x10^9/L in at least 3 consecutive samples post-transplant) after day 28 post-HAPLO.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Starting around 21 days post-transplant, with monitoring for at least 100 days after transplant
Participants receive a transfusion of donor-derived CMV-specific T lymphocytes (CMV-CTLs) approximately 21 days after their stem cell transplant if they are CMV-DNA sero-positive. This treatment aims to prevent CMV infection after transplant.
Weekly visits for CMV-DNA level monitoring for at least 100 days post-transplant
Duration - Up to 1 year after transplant
Participants are monitored for CMV infection and may receive antiviral drugs if a viral infection develops after CMV-CTL infusion. Follow-up continues up to 1 year post-transplant to assess long-term outcomes.
Visits as needed based on clinical condition
Trial Site Locations
Total: 1 location
1
Hospital Marques de Valdecilla
Santander, Spain
Actively Recruiting
Research Team
M
Miriam Sanchez-Escamilla, MD
L
Lucía Lavín Alconero, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here