Clinical trial NCT05315882: Cytomegalovirus Infection After HSCT and PT-CY as GVHD Prophylaxis >> GVHD PROPHYLAXIS ERA
Official title: Cytomegalovirus Infection, Indirect Effects and Mortality in Hematopoietic Stem Cell Transplantation With Cyclophosphamide Post-transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CMV Infection
Keywords: CMV
PT-CY
allogeneic stem cell transplantation
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-04-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 patients with hematological malignancies under HSCT from matched sibling donors, unrelated matched and mistmatched donor and haploidentical family donor using PT-CY and CNI as GVHD prophylaxis

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

Eligibility criteria: 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.

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Primary outcomes:
measure: Incidence of CMVi in HSCT with PT-Cy and CMVi requiring pre-emptive therapy (significant CMVi)
timeFrame: 1 year
measure: Median time to CMVi
timeFrame: 1 year
measure: Cumulative incidence of PET-CMVi by day +100, +180 and +365.
timeFrame: 1 year
measure: Overall survival by day +100, +180 and +365
timeFrame: 1 year
measure: Overall mortality by day +100, +180 and +365
timeFrame: 1 year
measure: Non-relapse mortality by day +100, +180 and +365
timeFrame: 1 year
Secondary outcomes:
measure: CMV indirect effects incidence
timeFrame: 1 year
measure: Incidence of CMVi recurrent episodes
timeFrame: 1 year
measure: CMV disease
timeFrame: 1 year
measure: CMV direct mortality
timeFrame: 1 year
measure: Cumulative incidence of II-IV aGvHD
timeFrame: 1 year
measure: Cumulative incidence of moderate-severe cGvHD
timeFrame: 1 year
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Maria Jesus Pascual
Study officials:
affiliation: HOSPITAL REGIONAL MALAGA / BMT UNIT
name: MARIA JESUS PASCUAL, MD
role: PRINCIPAL_INVESTIGATOR
References: