Rituximab for PTLD Prevention in Solid Organ Transplant Recipients With EBV DNAemia
NCT07614282
DNA Virus Infections, Epstein Barr Virus (EBV) Infection
View Trial DetailsNCT Number: NCT06422715
This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD.
The aim of the study is to analyze the clinical features and survival of patients who received a PTLD diagnosis with the target to assess a survival outcome, to obtain an epidemiologic and clinical characterization of the subpopulations affected by PTLD, to recognize unfavorable properties, to report the current treatment strategies, to provide rationale for the design of a prospective registry in order to develop future novel treatments.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia, Milan, MI, Italy
This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD. Retrospective data will be collected for all cases of PTLD diagnosed during a 10 years period since 1st January 2011 to 31th December 2021.
The following clinical characteristics of the patient at the time of PTLD diagnosis and pathology will be taken into consideration: positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted, and response obtained.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: from diagnosis of PTLD to patient's death / last FUP - up to 18 months.
survival after PTLD incidence rating
Time frame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
analyze the clinical and epidemiological features (e.g. positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted and response obtained) of PTLD patients
Time frame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
compare outcomes according to treatment approaches
Time frame: from treatment of PTLD to patient's death / last FUP - up to 18 months.
investigate potential treatment effect modifications on outcomes according to patient characteristics
Time frame: from treatment of PTLD to patient's death / last FUP - up to 18 months.
investigate potential treatment effect modifications on outcomes according to patient
Time frame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Overall Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant)
Time frame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Progression Free Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant)
Fondazione Italiana Linfomi - ETS
Other
Post-transplant Lymphoproliferative Disorders (PTLD): Multicentric Observational Retrospective Cohort Study
Acronym: FIL_PTLD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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