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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05315882

Acronym

CY-CMV-2020

Enrollment

300

Registered

2022-04-07

Start date

2020-02-14

Completion date

2020-12-17

Last updated

2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CMV Infection

Keywords

CMV, PT-CY, allogeneic stem cell transplantation

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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. 3\. Sirolimus as GvHD prophylaxis. 4\. HIV positive, HVC, HVB active or latent at HSCT. 5\. CMV prophylaxis with letermovir. \-

Design outcomes

Primary

Measure	Time frame
Non-relapse mortality by day +100, +180 and +365	1 year
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

Secondary

Measure	Time frame	Description
CMV indirect effects incidence	1 year	Hospital admissions, secondary infections, secondary toxicity.
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	—

Countries

Spain

Outcome results