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

CMV Infection Clinical Trial

— CY-CMV-2020  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05315882
• Other study ID #: FIM-CIC-2020-01
• Status: Completed
• Start date: February 14, 2020
• Est. completion date: December 17, 2020

Study information

• Verified date: March 2022
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 17, 2020
• Est. primary completion date: March 17, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• CMV Infection
• Communicable Diseases
• Cytomegalovirus Infections
• Infections

Locations

Country	Name	City	State
Spain	Maria Jesus Pascual	Malaga

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CMVi in HSCT with PT-Cy and CMVi requiring pre-emptive therapy (significant CMVi)		1 year
Primary	Median time to CMVi		1 year
Primary	Cumulative incidence of PET-CMVi by day +100, +180 and +365.		1 year
Primary	Overall survival by day +100, +180 and +365		1 year
Primary	Overall mortality by day +100, +180 and +365		1 year
Primary	Non-relapse mortality by day +100, +180 and +365		1 year
Secondary	CMV indirect effects incidence	Hospital admissions, secondary infections, secondary toxicity.	1 year
Secondary	Incidence of CMVi recurrent episodes		1 year
Secondary	CMV disease		1 year
Secondary	CMV direct mortality		1 year
Secondary	Cumulative incidence of II-IV aGvHD		1 year
Secondary	Cumulative incidence of moderate-severe cGvHD		1 year