Status:
COMPLETED
Cytomegalovirus Infection After HSCT and PT-CY as GVHD Prophylaxis >> GVHD PROPHYLAXIS ERA
Lead Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
CMV Infection
Eligibility:
All Genders
18+ years
Brief Summary
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 bo...
Detailed 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 comparin...
Eligibility Criteria
Inclusion
- Age \> 18 years.
- Period of HSCT: January 1st 2013 to December 31th 2018.
- GvHD prophylaxis: Post-transplantation Cyclophosphamide (50 mg/Kg on days +3 and +4 or +3 and +5) and calcineurine inhibitors as GvHD prophylaxis.
- 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
- Cord blood HSCT.
- Antilymphocytic or anti thymocytic thymoglobulin as GvHD prophylaxis.
- Alentuzumab as GvHD prophylaxis.
- 3\. Sirolimus as GvHD prophylaxis.
- 4\. HIV positive, HVC, HVB active or latent at HSCT.
- 5\. CMV prophylaxis with letermovir.
- \-
Key Trial Info
Start Date :
February 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 17 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05315882
Start Date
February 14 2020
End Date
December 17 2020
Last Update
April 7 2022
Active Locations (1)
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1
Maria Jesus Pascual
Málaga, Spain, 29010