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Taking peoplePhase 1

Linfociti T virus-specifici per infezioni virali resistenti alla terapia farmacologica dopo trapianto allogenico di cellule staminali emopoietiche e in pazienti con grave immunodepressione primitiva o secondaria

Key facts

Who runs it
IRCCS Istituto Giannina Gaslini
Where
Italy1 site in 1 countryChoose a country to see its sites
Status
Recruiting
Phase
Phase 1
People taking part
10 people, planned
Started
17 Jul 2024
Planned end
24 Jul 2025
Type of study
Interventional
Record updated
31 January 2025

Who can take part

Age
Up to 64 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Allogeneic transplant with any cells source and conditioning regimen
  • Presence of informed consent to the treatment of the patient / parent /legal guardian
  • Age between 0-30 years
  • Viral infection/reactivation (CMV, EBV, ADV, BK)
  • Absence of concomitant severe uncontrolled infections
  • Life expectancy exceeding 30 days
  • Absence of acute or chronic uncontrolled Graft versus Host Disease (GvHD)
  • Absence of acute kidney damage (creatinine value> 3 times the value normal with respect to age) not related to viral infection
  • Absence of severe acute liver injury (direct bilirubin> 3mg / dl or glutamicoxaloacetic transaminase -SGOT> 500 UI/L) not related to viral infection

Who cannot take part

  • Absence of a suitable donor (seronegativity for the virus in question and / or failure to respond to the secretion test)
  • Patient with severe renal and/or hepatic impairment as specified above
  • Primary or secondary graft failure
  • Relapse of malignant underlying disease

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The aim of the study is to evaluate the safety of virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV), BK that developed in young patients (age between 0 and 30 years) after allogeneic hematopoietic cell transplantation (allo-HSCT).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Virus-specific T-cell Immunity for the Treatment of Some Resistant Viral Infections After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Record updated
31 January 2025