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

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

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.

Study Overview

• Status: Completed
• Conditions: CMV Infection

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Spain
  • Malaga, Spain, 29010
    • Maria Jesus Pascual

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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.

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Allogeneic stem cell transplantation; Observational, no interventional

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: MARIA JESUS PASCUAL, MD, HOSPITAL REGIONAL MALAGA / BMT UNIT

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Actual): March 17, 2020
• Study Completion (Actual): December 17, 2020

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: CMV; allogeneic stem cell transplantation; PT-CY
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Disease Attributes; DNA Virus Infections; Herpesviridae Infections; Infections; Communicable Diseases; Cytomegalovirus Infections
• Other Study ID Numbers: FIM-CIC-2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Communication at the EBMT 2022 Prague congress
• IPD Sharing Time Frame: 19 March 2022
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No