Trial Information

A Retrospective Review of Reports of Hepatosplenic T-Cell Lymphoma in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief [PALGA]), a Database of Pathology Results for The Netherlands

A retrospective review of data from the medical records of patients with the diagnosis of
hepatosplenic T-cell lymphoma in the PALGA database Treatment Regimen(s): The PALGA registry
is observational and not interventional. All patients whose information is contained within
the PALGA database were prescribed treatments by a physician on the basis of usual clinical
practice or may have received other treatments, including experimental drugs, while
participating in an interventional clinical trial. Number of Patients: All patients
identified in the PALGA registry from 1995 to 2008 as having the diagnosis of HSTCL will be
assessed. It is estimated that additional data will be collected on 10 to 51 patients.
Number of Sites: It is estimated that additional data will be collected at approximately 10
to 26 sites. The Study Objectives are to: Evaluate the occurrence of the diagnosis of HSTCL
among patients with pathology reports in the PALGA database during the years 1995 to 2008;
Assess the factors associated with the diagnosis of HSTCL; Evaluate the prevalence (the
number of cases of a disease that are present in a particular population at a given time)
for HSTCL in the population of The Netherlands from 1995 to 2008; Evaluate the incidence
(the number of newly diagnosed cases during a specific time period) for HSTCL in the
population of The Netherlands from 1995 to 2008 (the incidence rate with 95% confidence
intervals [CI]); Evaluate the incidence of HSTCL prior to and after the availability of
infliximab in The Netherlands. Data Evaluation: 1. Descriptive statistics will be used to
summarize data for all patients diagnosed with HSTCL and will include (when available):
Comorbidities, including inflammatory bowel disease (IBD) (Crohn's disease, ulcerative
colitis, and indeterminate colitis); Malignancy/lymphoma history; Type and duration of
treatment with corticosteroids and any immunomodulator therapies (including biologics) prior
to and at time of diagnosis of lymphoma; Cytogenetics. 2. The prevalence and incidence of
the diagnosis of HSTCL will be assessed relative to the overall population in The
Netherlands during the same time period (incidence rates with 95% CI). The prevalence and
incidence of the diagnosis of HSTCL will also be assessed relative to the known populations
in The Netherlands with particular risk factors for the disease (eg, post-transplantation
patients) during the same period. If any of the cases involve IBD, the prevalence and
incidence of the diagnosis of HSTCL will also be assessed relative to the known populations
in The Netherlands with IBD during the same period. 3. The incidence of the diagnosis of
HSTCL prior to and after the availability of infliximab in The Netherlands will be assessed.
Rationale for Study Design: Over recent years, a number of postmarketing case reports of
HSTCL have been received on patients who had received treatment with Remicade. Most of these
reports were from the US and concerned adolescent and young adult patients with inflammatory
bowel disease (IBD) (CD, UC, or indeterminant colitis) who concomitantly had been treated
with azathioprine or 6-mercaptopurine. As there is virtually no information currently
available on the epidemiology and pathogenesis of HSTCL, the reports of this type of
lymphoma associated with the use of Remicade are difficult to assess. More information about
the background incidence of this malignancy in the population to be treated with Remicade is
needed for the evaluation of this potential safety signal. This study, aimed at estimating
the prevalence and incidence of HSTCL lymphoma in a well-described population of 16 million
over a defined period of time with a 100% capture of pathology reports, represents a novel
way of using the unique PALGA system and database for assessing the occurrence of a rare
type of malignancy. In addition, the study will report on the characteristics of the
patients who developed HSTCL whose pathology reports were in the PALGA registry during the
data collection period (ie, 1995 to 2008). Considering the low numbers of cases of HSTCL,
the report will primarily be of a descriptive nature. However, since Remicade was approved
for use in The Netherlands in 1999 (the first recorded use of the agent occurring in 1999)
there may be some information available concerning the relative occurrence prior to and
after Remicade use (assuming there are any cases involving exposure to Remicade or other
anti-TNF agents in the PALGA registry).

This is an observational study. No dosage administered.