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Completed

NCT Number: NCT05315882

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

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.

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Key information

Conditions

CMV Infection Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maria Jesus Pascual

Málaga, 29010, Spain

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.
  • Sirolimus as GvHD prophylaxis.
  • HIV positive, HVC, HVB active or latent at HSCT.
  • CMV prophylaxis with letermovir.

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Treatment and study plan

Primary outcomes

  1. Incidence of CMVi in HSCT with PT-Cy and CMVi requiring pre-emptive therapy (significant CMVi)

    Time frame: 1 year

  2. Median time to CMVi

    Time frame: 1 year

  3. Cumulative incidence of PET-CMVi by day +100, +180 and +365.

    Time frame: 1 year

  4. Overall survival by day +100, +180 and +365

    Time frame: 1 year

  5. Overall mortality by day +100, +180 and +365

    Time frame: 1 year

  6. Non-relapse mortality by day +100, +180 and +365

    Time frame: 1 year

Secondary outcomes

  1. CMV indirect effects incidence

    Time frame: 1 year

    Hospital admissions, secondary infections, secondary toxicity.

  2. Incidence of CMVi recurrent episodes

    Time frame: 1 year

  3. CMV disease

    Time frame: 1 year

  4. CMV direct mortality

    Time frame: 1 year

  5. Cumulative incidence of II-IV aGvHD

    Time frame: 1 year

  6. Cumulative incidence of moderate-severe cGvHD

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: CY-CMV-2020

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 7, 2022
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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