Clinical trial NCT02856646: Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices
Official title: Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin's Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-08-05
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community Sample

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


Eligibility 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

Primary outcomes:
measure: Composite of Treatment Patterns
timeFrame: Up to five years
measure: Overall Survival (OS)
timeFrame: Up to five years
measure: Progression Free Survival (PFS)
timeFrame: Up to five years
measure: Duration of Response
timeFrame: Up to five years
measure: Percentage of patients who achieve complete response
timeFrame: Up to 5 years
measure: Percentage of patients who achieve partial response
timeFrame: Up to 5 years
Secondary outcomes:
measure: Health-related quality of life (HRQoL)
timeFrame: Up to five years
measure: Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
timeFrame: Up to five years
measure: Drivers of Treatment Choice
timeFrame: Up to five years
measure: Healthcare resource utilization measured by imputed costs
timeFrame: Up to five years
measure: Grade of AE
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: