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

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

Study Overview

• Status: Completed
• Conditions: Hodgkin's Disease

• Study Type: Observational
• Enrollment (Actual): 290

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Community Sample

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Population with Condition; Community Sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	What are drivers of choice (eg. lack of response, safety, cost or other barriers to care) for: treatment decisions across and between drug classes, changes and/or discontinuation in treatment, determinants of transplant eligibility/in-eligibility?	Up to five years
Healthcare resource utilization measured by imputed costs		Up to five years
Grade of AE		Up to 5 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2016
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease
• Other Study ID Numbers: CA209-655