Clincosm LogoSign in Get a demo

CY-CMV-2020: Cytomegalovirus Infection After HSCT and PT-CY as GVHD Prophylaxis >> GVHD PROPHYLAXIS ERA

Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (Other)
Overall Status
Completed
CT.gov ID
NCT05315882
Collaborator
Merck Sharp & Dohme LLC (Industry)
300
Enrollment
1
Location
10.1
Actual Duration (Months)
29.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Cytomegalovirus Infection, Indirect Effects and Mortality in Hematopoietic Stem Cell Transplantation With Cyclophosphamide Post-transplant
    Actual Study Start Date :
    Feb 14, 2020
    Actual Primary Completion Date :
    Mar 17, 2020
    Actual Study Completion Date :
    Dec 17, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Allogeneic stem cell transplantation

    Observational, no interventional

    Outcome Measures

    Primary Outcome Measures

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

    2. Median time to CMVi [1 year]

    3. Cumulative incidence of PET-CMVi by day +100, +180 and +365. [1 year]

    4. Overall survival by day +100, +180 and +365 [1 year]

    5. Overall mortality by day +100, +180 and +365 [1 year]

    6. Non-relapse mortality by day +100, +180 and +365 [1 year]

    Secondary Outcome Measures

    1. CMV indirect effects incidence [1 year]

      Hospital admissions, secondary infections, secondary toxicity.

    2. Incidence of CMVi recurrent episodes [1 year]

    3. CMV disease [1 year]

    4. CMV direct mortality [1 year]

    5. Cumulative incidence of II-IV aGvHD [1 year]

    6. Cumulative incidence of moderate-severe cGvHD [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maria Jesus Pascual Malaga Spain 29010

    Sponsors and Collaborators

    • Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: MARIA JESUS PASCUAL, MD, HOSPITAL REGIONAL MALAGA / BMT UNIT

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
    ClinicalTrials.gov Identifier:
    NCT05315882
    Other Study ID Numbers:
    • FIM-CIC-2020-01
    First Posted:
    Apr 7, 2022
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
    CMV
    PT-CY
    allogeneic stem cell transplantation
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Cytomegalovirus Infections

    Study Results

    No Results Posted as of Apr 7, 2022