Cytomegalovirus Infection After HSCT and PT-CY as GVHD Prophylaxis >> GVHD PROPHYLAXIS ERA

Study Overview
=================
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 both postransplant cyclophosphamide as GvHD prophylaxis, using a database with information from historical clinic data.

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 comparing two cohorts: haploidentical HSCT vs no haploidentical HSCT

Official Title
-----------------
Cytomegalovirus Infection, Indirect Effects and Mortality in Hematopoietic Stem Cell Transplantation With Cyclophosphamide Post-transplant

Conditions
-----------------
CMV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Allogeneic stem cell transplantation<br>Observational, no interventional | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CMVi in HSCT with PT-Cy and CMVi requiring pre-emptive therapy (significant CMVi) |  | 1 year | 
| Median time to CMVi |  | 1 year | 
| Cumulative incidence of PET-CMVi by day +100, +180 and +365. |  | 1 year | 
| Overall survival by day +100, +180 and +365 |  | 1 year | 
| Overall mortality by day +100, +180 and +365 |  | 1 year | 
| Non-relapse mortality by day +100, +180 and +365 |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMV indirect effects incidence | Hospital admissions, secondary infections, secondary toxicity. | 1 year | 
| Incidence of CMVi recurrent episodes |  | 1 year | 
| CMV disease |  | 1 year | 
| CMV direct mortality |  | 1 year | 
| Cumulative incidence of II-IV aGvHD |  | 1 year | 
| Cumulative incidence of moderate-severe cGvHD |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CMV, PT-CY, allogeneic stem cell transplantation