A Blood and Tissue Sample Collection Study of Patients Who Have Inflammatory Bowel Disease, Who Have Been Treated With Adalimumab and Who Developed Hepatosplenic T-Cell Lymphoma (HSTCL)

• ClinicalTrials.gov Identifier: NCT02087878
• Recruitment Status: Withdrawn
• First Posted: March 14, 2014
• Last Update Posted: November 22, 2019
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Study Description

Brief Summary:

To collect and store blood and biopsy samples obtained from CD or UC patients exposed to adalimumab and diagnosed with Hepatosplenic T-cell Lymphoma (HSTCL), for the purpose of identifying potential biomarkers and genetic mutations in patients who have developed HSTCL.

Condition or disease
Crohn's Disease; Ulcerative Colitis (UC); Hepatosplenic T-Cell Lymphoma

Detailed Description:

A study to bank samples for future evaluation to identify genetic mutations and other biomarkers that predispose inflammatory bowel disease (IBD) patients to developing Hepatosplenic T-cell Lymphoma (HSTCL).

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: A Multicenter Study to Collect Samples for Future Evaluation of Biomarkers and Genetic Mutations in Patients Exposed to Adalimumab With Crohn's Disease (CD) or Ulcerative Colitis (UC) Who Developed Hepatosplenic T-Cell Lymphoma (HSTCL)
• Actual Study Start Date: March 31, 2014
• Actual Primary Completion Date: September 30, 2019
• Actual Study Completion Date: September 30, 2019

Groups and Cohorts

Group/Cohort
Group 1; To collect and store blood and biopsy samples obtained from CD or UC patients exposed to adalimumab and diagnosed with HSTCL for the purpose of identifying potential biomarkers and genetic mutations in patients who develop HSTCL.

Outcome Measures

Primary Outcome Measures :

1. Collection of Samples [ Time Frame: Up to 6 years ]
   A study to bank blood and tissue samples for future evaluation to identify genetic mutations and other biomarkers that predispose inflammatory bowel disease (IBD) patients to developing Hepatosplenic T-Cell Lymphoma (HSTCL). Samples will be obtained from patients who have Crohn's Disease or Ulcerative Colitis, who have been treated with adalimumab and diagnosed with HSTCL.

Biospecimen Retention:   Samples With DNA

1-10 mL blood (serum) for biomarker samples; separate consent for 1- 4 mL whole blood sample for DNA isolation. Biopsy tissue and Fine Needle Aspirate also collected. Samples will be shipped to a designated storage facility.

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 99 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients of any age with CD or UC in the US with HSTCL who are identified through the Sponsor's adverse event reporting systems and who were exposed to HUMIRA prior to the diagnosis of HSTCL.

Criteria

Inclusion Criteria:

• Male or female who has received a single dose of HUMIRA prior to a confirmed diagnosis of HSTCL.
• Confirmed diagnosis of CD or UC as documented by a Gastroenterologist or physician who diagnosed the CD or UC.
• Confirmed diagnosis of HSTCL as determined by a biopsy performed on a specimen taken from the patient.
• Patients 18 years old and older must voluntarily sign and date an IRB/EC approved Informed Consent Form. For patients younger than 18 years old, a parent or legal guardian is required to voluntarily sign and date an IRB/EC approved Informed Consent Form. Pediatric patients will be included in all discussions if possible, in order to obtain their assent.

Exclusion Criteria:

• Male or female who has not received at least a single dose of adalimumab prior to a confirmed diagnosis of HSTCL.
• Unconfirmed diagnosis of HSTCL, CD or UC, respectively.
• The patient or the patient's HCP is unwilling to participate in this study.
• The parents or legal guardians (in the case of patients younger than 18 years of age), who are unable and/or unwilling to consent to the patient's participation in this study.

Contacts and Locations

Locations

Italy

AOU Pisana /ID# 208952

Pisa, Italy, 56124

Sponsors and Collaborators

AbbVie

Investigators

• Study Director: AbbVie Inc.; AbbVie

More Information

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02087878
• Other Study ID Numbers: F14-258
• First Posted: March 14, 2014
• Last Update Posted: November 22, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:

Hepatosplenic T-Cell Lymphoma

Additional relevant MeSH terms:

Crohn Disease; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases; Lymphoma; Lymphoma, T-Cell; Colitis; Colitis, Ulcerative; Ulcer; Neoplasms by Histologic Type; Neoplasms; Gastroenteritis; Pathologic Processes; Lymphoma, Non-Hodgkin