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Recruiting NCT04056533

Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy

Phase II Interventional CMV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CMV CTLs.
Who it may be relevant to
Registry conditions: CMV. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

In HAPLO, CMV infection and disease are more frequent than in other type of HSCT, this is related to delayed immune reconstitution after transplant increasing post-transplant infectious complications. Approximately 60% of patients reactivated CMV infection after HAPLO and 15%, developed CMV disease afecting organs and causing the death of the patient in 8% of CMV disease cases.

If patient and donor are eligible, it will take 1x10\^9 cells from donor leukapheresis. Donor cells will be selected and procesed by CliniMACs PRODIGY and after 12h it will obtain 7mL of CMV-CTLs. It will use 6mL of CMV-CTLs to infused a dose of 1x10\^5 cells/kg in our patient. The donor derived CMV-CTL cells will be transfused into the patients' intravenous line. The patients will receive the dose of CMV-CTL cells when they are sero-positive for CMV-DNA 21 (+- 7 days) days after transplant.

The CMV-DNA levels will be monitored weekly for at least 100 days after the transplant. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then the patient will receive treatment with anti-CMV comercial drugs.

Interventions

  • Biological CMV CTLs
    The donor derived cytomegalovirus specific T lymphocytes (CMV-CTL) will be transfused to the patients. The patients will receive CMV-CTL cells when their donors are sero-positive for CMV-DNA 21 days after transplant. The CMV-DNA levels will be monitored weekly for at least 100 days after the HAPLO. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then they may be eligible to receive a CMV specific antiviral drug.

Primary outcome measures

  • 100-days incidence of CMV infection [Time frame: From date of CMV-CTLs infusion to 100 days after transplant]
Secondary outcome measures (2)
  • 1-year incidence of CMV specific antiviral drug use [Time frame: From date of CMV-CTLs infusion to 1 year after transplant]
  • 1-year incidence of CMV disease [Time frame: From date of CMV-CTLs infusion to 1 year after transplant]

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:
  • HLA haploidentical and CMV-seropositve donors.
  • Donor must be checked and suitable.
  • Signed writen informed consent.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Spain · 1 center
  • Hospital Marques de Valdecilla — Santander

Identifiers

NCT: NCT04056533 · INMUNOCELL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗