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

NCT05315882 | Completed DMC

• 1 other identifier: FIM-CIC-2020-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

CMV Infection

Keywords

CMV; PT-CY; allogeneic stem cell transplantation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• CMV indirect effects incidence

  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

Study Arms (1)

Allogeneic stem cell transplantation

Observational, no interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Maria Jesus Pascual

Málaga, 29010, Spain

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• MARIA JESUS PASCUAL, MD

  HOSPITAL REGIONAL MALAGA / BMT UNIT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 7, 2022
• Study Start: February 14, 2020
• Primary Completion: March 17, 2020
• Study Completion: December 17, 2020
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: 19 March 2022

Locations

ES (1)