Hepatosplenic T-Cell Lymphoma
Conditions
Keywords
Lymphoma, T-Cell, Peripheral, Infliximab, Golimumab, Remicade, Simponi, Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease
Brief summary
This study is designed to collect tissue samples from the biopsy specimen that was used to diagnose hepatosplenic T-cell lymphoma (HSTCL), additional patient information, and if possible, to obtain additional samples including a single blood sample, a buccal swab sample and/or a bowel tissue sample. Samples obtained will be stored by the sponsor for future testing. In addition, demographic and clinical patient information will be collected. The study will be conducted in North America. Patients eligible for enrollment include males or females with IBD of any age who have a confirmed diagnosis of HSTCL. Patients will be identified through the sponsor's adverse event reporting systems. Cases reported to the sponsor's Medical Information Center will be queried to ascertain if the reporter is interested in participating in the study. Where appropriate, cases may also be identified through the sponsor's new or on-going clinical trials and registries. Samples may be collected from living patients or from stored tissue of deceased patients. This study will not restrict or introduce any therapeutic interventions, including medications. All patients will continue to be managed by their personal physicians. No healthy subjects will be enrolled in this study.
Interventions
DRUGInfliximab
This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive infliximab as instructed by their personal physicians.
DRUGGolimumab
This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive golimumab as instructed by their personal physicians.
Sponsors
Janssen Scientific Affairs, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with Inflammatory Bowel Disease with a confirmed diagnosis of Hepatosplenic T-cell Lymphoma * Provide written informed consent (either by the patient or his/her legal representative). Consent from a legally acceptable representative of a deceased patient will be obtained for enrollment into the study and sample collection * Be willing to provide a tumor biopsy sample for the study
Exclusion criteria
* Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments * Is unable to provide critical clinical and/or demographic patient and/or sample information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Samples Collected for the Identification of Biomarkers for Early Evaluation of Risk of Developing Hepatosplenic T-cell Lymphoma (HSTCL) | Approximately up to 8 years | Samples will be collected from IBD patients diagnosed with HSTCL for future evaluation to identify biomarkers that may allow either earlier evaluation of a participant's risk of developing HSTCL or possibly earlier diagnosis. |
Countries
United States
Participant flow
Recruitment details
Of the 12 subjects the Sponsor attempted to enroll in the study, 1 subject consented and provided a biopsy sample for analysis. No subjects discontinued from the study after enrollment.
Participants by arm
| Arm | Count |
|---|---|
| IBD Patients With HSTCL Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Number of Samples Collected for the Identification of Biomarkers for Early Evaluation of Risk of Developing Hepatosplenic T-cell Lymphoma (HSTCL)
Samples will be collected from IBD patients diagnosed with HSTCL for future evaluation to identify biomarkers that may allow either earlier evaluation of a participant's risk of developing HSTCL or possibly earlier diagnosis.
Time frame: Approximately up to 8 years
Population: Since only one participant completed the study, due to confidentiality issues, no data will be reported.