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CA209655: Hodgkin Lymphoma, Observational

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

Objective

Overview

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

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
  • Men and women ≥ 18 years of age.
  • Histologically confirmed diagnosis of Classical Hodgkin Lymphoma (cHL).
  • Patients who are treatment-naïve or are within ± 2 weeks of Day 1 of Cycle 1 of 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.
    • Patients enrolled, who receive anti-cancer therapy, and 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.
  • Any Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status (PS).
  • Patients must have available medical records for the date of diagnosis of cHL.
  • Patients must have available medical records documenting any prior treatment and treatment dates for the Hodgkin lymphoma, including chemotherapy, radiation, surgery and other anticancer therapy received.
  • Patients must consent to use their FPFE tissue blocks, blood or serum samples, (obtained via SOC visits) for exploratory analyses.

Key Exclusion Criteria

A patient will not be eligible for participation in this study if any of the following criteria apply.
  • Patients with unknown date of diagnosis of cHL.
  • Patients whose prior therapy and dates of therapy (eg, surgery, radiation, or drug therapy) are unknown.
  • Any other (non-HL) active malignancy for which the patient is receiving treatment.
  • Patients participating in a clinical study that does not allow enrollment into a noninterventional study.
  • At time of enrollment, patients who are receiving supportive, palliative, hospice or end-of-life care only and not receiving anti-cancer therapy will be excluded.
    • Patients enrolled who receive anti-cancer therapy, and 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.

Phase: N/A

Learn More

ClinicalTrials.Gov

    IRB Protocol Number
    CA209655
    Principal Investigator(s)
    Asim Pati, M.D

    Clinical Trial Categories

    • Hematologic Cancer
    Sponsor(s)
    Bristol-Myers Squibb
    How to Participate

    Tom Leuck, RN

    864-560-1980

    tleuck@gibbscc.org

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