PTC:VS-TC for Post-transplant viral reactivation after allogeneic haematopoietic stem cell transplantation|Cytomegalovirus infection (CMV)|Epstein–Barr virus infection (EBV)|Adenovirus infection (ADV)|BK virus infection

Inclusion criteria

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

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Adverse events: To collect any adverse event defined as any significant alteration of vital signs and / or organ function, expressed in clinical, hematochemical and radiological findings according to version 5 of the Common Terminology Criteria for Adverse Events (CTCAE)","definition_or_measurement_approach":"Adverse events collected and graded according to version 5 of the Common Terminology Criteria for Adverse Events (CTCAE); includes clinical, laboratory (hematochemical) and radiological findings."}

Secondary endpoints

• {"endpoint_text":"- Organ damage; overall survival; specific cell viral immunity; variation of viremia.","definition_or_measurement_approach":"No detailed measurement definitions provided beyond the endpoint listing; likely includes clinical assessment for organ damage, survival follow-up, immunological assays for specific cell viral immunity and viral load (viremia) measurements, but specific methods/timings are not specified."}

Italy

Earliest CTIS Part Ii Submission Date

13-01-2025

Latest Decision Or Authorization Date

31-01-2025

Processing Time Days

18

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

IRCCS Istituto Giannina Gaslini

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy