Cytomegalovirus Infection After HSCT and PT-CY as GVHD Prophylaxis >> GVHD PROPHYLAXIS ERA (CY-CMV-2020)

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Status: Completed

Conditions: CMV Infection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05315882

FIM-CIC-2020-01

Details and patient eligibility

About

Multicentre, observational, retrospective study to analyze the differences in CMVi pattern and recurrences between two groups of allogeneic HSCT patients (haplo vs no haplo HSCT), with intervention both postransplant cyclophosphamide as GvHD prophylaxis, using a database with information from historical clinic data.

Full description

The overall aim of the study is to to analize CMVi after PTCy for GVHD prophylaxis, with a detailed description of CMVi and recurrences, direct and indirect consequences, in a HSCT population comparing two cohorts: haploidentical HSCT vs no haploidentical HSCT

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 18 years.
2. Period of HSCT: January 1st 2013 to December 31th 2018.
3. GvHD prophylaxis: Post-transplantation Cyclophosphamide (50 mg/Kg on days +3 and +4 or +3 and +5) and calcineurine inhibitors as GvHD prophylaxis.
4. Conditioning chemotherapy regimen and source of stem cells: myeloablative or reduced intensity TBF (Thiotepa 5 mg/Kg D -7-6, Fludarabine 50 mg/m2 D -5-4-3, Busulfan 3,2 mg/Kg D -4-3-2) starting on D-7 followed by peripheral blood or bone marrow infusion on day 0.

Exclusion criteria

1. Cord blood HSCT.

2. Antilymphocytic or anti thymocytic thymoglobulin as GvHD prophylaxis.

3. Alentuzumab as GvHD prophylaxis.

4. Sirolimus as GvHD prophylaxis.

5. HIV positive, HVC, HVB active or latent at HSCT.

6. CMV prophylaxis with letermovir.

Trial design

300 participants in 1 patient group

Allogeneic stem cell transplantation

Description:

Observational, no interventional