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

Completed

• Conditions: Hodgkin's Disease

• Registration Number: NCT02856646
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Study Start: 2016-10-07
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
Duration of Response	Up to five years
Overall Survival (OS)	Up to five years
Percentage of patients who achieve complete response	Up to 5 years
Progression Free Survival (PFS)	Up to five years
Percentage of patients who achieve partial response	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Grade of AE	Up to 5 years
Health-related quality of life (HRQoL)	Up to five years
Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)	Up to five years
Healthcare resource utilization measured by imputed costs	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?

Trial Locations

Locations (1)

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States