Preventing Cytomegalovirus Infection After Stem Cell Transplantation

Anti-CMV Pilot Clinical Trial: Prophylaxis of Cytomegalovirus Infection in Haploidentical Transplatation of Hematopoietic Progenitors With Adoptive Cell Inmunotherapy

This study is testing whether giving patients special immune cells from their donors can help prevent Cytomegalovirus infections after they receive a stem cell transplant.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Instituto de Investigación Marqués de Valdecilla (other)
• Drugs / interventions: prednisone, immunotherapy
• Locations: 1 site (Santander)
• Trial ID: NCT04056533 on ClinicalTrials.gov

What this trial studies

This study investigates the use of donor-derived Cytomegalovirus-specific T lymphocytes (CMV-CTLs) as a preventive measure against CMV infection in patients who have undergone haploidentical hematopoietic stem cell transplantation (HSCT). The CMV-CTLs will be administered to patients approximately 21 days post-transplant, and their CMV DNA levels will be monitored weekly for at least 100 days. The goal is to reduce the incidence of CMV reactivation and associated complications in this high-risk patient population. The study aims to improve patient outcomes by enhancing immune response against CMV.

Who should consider this trial

Good fit: Ideal candidates include adult patients who have received haploidentical stem cell transplants from CMV-seropositive donors.

Not a fit: Patients without haploidentical CMV-seropositive donors or those unsuitable for follow-up visits may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of CMV infection and related complications in stem cell transplant recipients.

How similar studies have performed: Other studies have shown promise in using adoptive cell therapy for CMV prevention, indicating potential success for this approach.

Eligibility criteria

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 don´t fill infusion criteria, after day 28 post-HAPLO, will be considered screening failures and will be out of the study.

Where this trial is running

Santander

• Hospital Marques de Valdecilla — Santander, Spain (RECRUITING)

Study contacts

• Study coordinator: Miriam Sanchez-Escamilla, MD

Conditions: CMV, Citomegalovirus, Haploidentical, Hematopoietic Stem Cell Transplantation