Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy

Recruiting now · Phase 2

Conditions studied: CMV

In brief

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.

Key facts

Study ID

NCT04056533

Run by

Instituto de Investigación Marqués de Valdecilla

People needed

15

Starts

2022-03-26

Expected to finish

2026-12-01

Last updated by the study team

2024-08-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• HLA haploidentical and CMV-seropositve donors.
• Donor must be checked and suitable.
• Signed writen informed consent.
• Donor without active infection evidence at leukapheresis.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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