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OpenTrials
Completed

NCT Number: NCT02856646

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. Overall Survival (OS)

    Time frame: Up to five years

  3. Progression Free Survival (PFS)

    Time frame: Up to five years

  4. Duration of Response

    Time frame: Up to five years

  5. Percentage of patients who achieve complete response

    Time frame: Up to 5 years

  6. Percentage of patients who achieve partial response

    Time frame: Up to 5 years

Secondary outcomes

  1. Health-related quality of life (HRQoL)

    Time frame: Up to five years

  2. Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)

    Time frame: Up to five years

  3. 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?

  4. Healthcare resource utilization measured by imputed costs

    Time frame: Up to five years

  5. Grade of AE

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2016
Registry last updated
Dec 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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