Cytomegalovirus Infection After HSCT and PT-CY as GVHD Prophylaxis >> GVHD PROPHYLAXIS ERA
NCT ID: NCT05315882
Last Updated: 2022-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2020-02-14
2020-12-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Allogeneic stem cell transplantation
Observational, no interventional
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
\-
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
OTHER
Responsible Party
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Principal Investigators
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MARIA JESUS PASCUAL, MD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL REGIONAL MALAGA / BMT UNIT
Locations
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Maria Jesus Pascual
Málaga, , Spain
Countries
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Other Identifiers
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FIM-CIC-2020-01
Identifier Type: -
Identifier Source: org_study_id
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