Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices

NCT02856646 | Completed

• 1 other identifier: CA209-655
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to gather data on patients diagnosed with and treated for classical Hodgkin Lymphoma (cHL). It aims to closely observe how treatment for cHL is rendered, as well as assess the outcome of those treatment options and their impact on quality of life. Additional analyses will also attempt to identify prognostic or predictive biomarkers

Conditions

Hodgkin's Disease

Outcome Measures

Primary Outcomes (6)

• Composite of Treatment Patterns

  What are the treatment patterns of therapies used to treat cHL (ie, incorporation of novel chemotherapy or non-chemotherapy to upfront therapy, chemotherapy/radiation and/or transplant sparring patterns, incorporation of immune checkpoint agents or other investigational therapies)

  Up to five years

• Overall Survival (OS)

  Up to five years

• Progression Free Survival (PFS)

  Up to five years

• Duration of Response

  Up to five years

• Percentage of patients who achieve complete response

  Up to 5 years

• Percentage of patients who achieve partial response

  Up to 5 years

Secondary Outcomes (5)

• Health-related quality of life (HRQoL)

  Up to five years

• Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)

  Up to five years

• Drivers of Treatment Choice

  Up to five years

• Healthcare resource utilization measured by imputed costs

  Up to five years

• Grade of AE

  Up to 5 years

Study Arms (1)

Population with Condition

Community Sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community Sample

You may qualify if:

• Histologically confirmed diagnosis of Classical Hodgkin Lymphoma (cHL)
• Patients who are treatment-naïve, or are within ± 2 weeks beginning any line of therapy at time of enrollment
• Patients must be within ± 2 weeks of Day 1 of the first cycle of any line of therapy to enroll; a cycle is practice-defined for chemotherapy, targeted therapy, or immunotherapy-based regimens.
• Any Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status (PS)
• Patients must have available medical records for the date of diagnosis of cHL and available medical records documenting any prior treatment and treatment dates for the Hodgkin lymphoma, including chemotherapy, radiation, surgery and other anti-cancer therapy received.
• Patients must consent for use of their FFPE tissue blocks for exploratory analyses

You may not qualify if:

• Patients on supportive care only and not receiving anti-cancer therapy are not eligible to enroll
• Patients with unknown date of diagnosis of cHL
• Patients whose prior cHL therapy, and dates of therapy (eg, surgery, radiation, or drug therapy) are unknown
• Any other non-HL (non-Hodgkin Lymphoma) active malignancy for which the patient is receiving treatment
• Patients participating in a clinical study that does not allow enrollment into a non-interventional study
• Patients enrolled who go on to receive only supportive, palliative, hospice, or end-of-life care remain on study and should not be discontinued from follow-up.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 5, 2016
• Study Start: October 7, 2016
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

US (1)