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

Hodgkin's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856646
• Other study ID #: CA209-655
• Status: Completed
• Start date: October 7, 2016
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease

Locations

Country	Name	City	State
United States	Norton Cancer Institute	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Treatment Patterns	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)	Up to five years
Primary	Overall Survival (OS)		Up to five years
Primary	Progression Free Survival (PFS)		Up to five years
Primary	Duration of Response		Up to five years
Primary	Percentage of patients who achieve complete response		Up to 5 years
Primary	Percentage of patients who achieve partial response		Up to 5 years
Secondary	Health-related quality of life (HRQoL)		Up to five years
Secondary	Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)		Up to five years
Secondary	Drivers of Treatment Choice	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?	Up to five years
Secondary	Healthcare resource utilization measured by imputed costs		Up to five years
Secondary	Grade of AE		Up to 5 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls