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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Hodgkin's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02856646

CA209-655

Details and patient eligibility

About

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

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

290 participants in 1 patient group

Population with Condition

Description:

Community Sample