A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)

NCT01804166 | Completed Phase 4 Results

• 1 other identifier: CR100938
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatosplenic T-Cell Lymphoma

Keywords

Lymphoma, T-Cell, Peripheral, Infliximab, Golimumab, Remicade, Simponi, Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately up to 8 years

Study Arms (1)

IBD patients with HSTCL

OTHER

Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma

Drug: Infliximab; Drug: Golimumab

Interventions

Infliximab DRUG

This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive infliximab as instructed by their personal physicians.

Also known as: Remicade

IBD patients with HSTCL

Golimumab DRUG

This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive golimumab as instructed by their personal physicians.

Also known as: Simponi

IBD patients with HSTCL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: lead

Study Sites (1)

Unknown Facility

Norfolk, Virginia, United States

Location

MeSH Terms

Conditions

Lymphoma; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Interventions

Infliximab; golimumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The low enrollment in this study combined with the limited published information related to biomarkers related to HSTCL limit the ability to interpret and apply any results from this study to the broader IBD population.

Results Point of Contact

• Title: Executive Medical Director
• Organization: Janssen Scientific Affairs, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Study Director

  Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: March 5, 2013
• Study Start: March 21, 2013
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: February 4, 2025
• Results First Posted: March 4, 2021

Record last verified: 2025-01

Locations

US (1)