Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Population with Condition Community Sample |
Outcome Measures
Primary Outcome Measures
- Composite of Treatment Patterns [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) [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
- 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]
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 [Up to five years]
- Grade of AE [Up to 5 years]
Eligibility Criteria
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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Histologically confirmed diagnosis of Classical Hodgkin Lymphoma (cHL)
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Patients who are treatment-naïve, or are within ± 2 weeks beginning any line of therapy at time of enrollment
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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.
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Any Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status (PS)
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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.
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Patients must consent for use of their FFPE tissue blocks for exploratory analyses
Exclusion Criteria:
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Patients on supportive care only and not receiving anti-cancer therapy are not eligible to enroll
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Patients with unknown date of diagnosis of cHL
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Patients whose prior cHL therapy, and dates of therapy (eg, surgery, radiation, or drug therapy) are unknown
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Any other non-HL (non-Hodgkin Lymphoma) active malignancy for which the patient is receiving treatment
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Patients participating in a clinical study that does not allow enrollment into a non-interventional study
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Norton Cancer Institute | Louisville | Kentucky | United States | 40207 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CA209-655