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

Completed

• Conditions: CMV Infection

• Registration Number: NCT05315882
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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

Study Timeline

• Study Start: 2020-02-14
• Primary Completion: 2020-03-17
• Study Completion: 2020-12-17
• Status Verified: 2022-03
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-30
• Last Update Submitted: 2022-03-30
• Study First Posted: 2022-04-07
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maria Jesus Pascual; 🇪🇸 Malaga, Spain