Preventing Cytomegalovirus Infection After Stem Cell Transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Marques de Valdecilla
  Santander, Spain Recruiting

Study contacts

• Study coordinator: Miriam Sanchez-Escamilla, MD
• Email: msanchez@idival.org
• Phone: +34646393234

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Family-donor viral CTLs plus standard care vs standard care alone for refractory ADV or CMV infection after stem cell transplant

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• Preventing CMV with CMVIG after conversion to belatacept in kidney transplant recipients

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  Recruiting Phase 1/2 University of Minnesota · Minneapolis, Minnesota · NCT07096453

• Preventing CMV Infections in High-Risk Adults After Stem Cell Transplant

  This study is testing if giving a medication called letermovir for longer than usual can help prevent serious CMV infections in high-risk adults after they receive a stem cell transplant.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT06812598

• Evaluating CMV Prophylaxis After Stem Cell Transplant

  This study is testing if a new test can help doctors decide how long to give a specific medicine to prevent a virus in patients who have had a stem cell transplant.

  Recruiting Phase 2 University of California, Irvine · Orange, California · NCT06453460

• Understanding severe viral infections in patients without known immune issues

  This study is trying to understand why some healthy people get severe viral infections and how different tests can help figure it out.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT01011712

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.