Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices
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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
Composite of Treatment Patterns [ Time Frame: Up to five years ]
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)
Overall Survival (OS) [ Time Frame: Up to five years ]
Progression Free Survival (PFS) [ Time Frame: Up to five years ]
Duration of Response [ Time Frame: Up to five years ]
Percentage of patients who achieve complete response [ Time Frame: Up to 5 years ]
Percentage of patients who achieve partial response [ Time Frame: Up to 5 years ]
Secondary Outcome Measures :
Health-related quality of life (HRQoL) [ Time Frame: Up to five years ]
Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) [ Time Frame: Up to five years ]
Drivers of Treatment Choice [ Time Frame: Up to five years ]
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?
Healthcare resource utilization measured by imputed costs [ Time Frame: Up to five years ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
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
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