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

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ClinicalTrials.gov Identifier: NCT02856646
Recruitment Status : Recruiting
First Posted : August 5, 2016
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease
Hodgkin's Disease

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices
Actual Study Start Date : September 21, 2016
Estimated Primary Completion Date : September 28, 2023
Estimated Study Completion Date : September 28, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Population with Condition
Community Sample



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Community Sample
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856646


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
United States, New Jersey
Inventiv Clinical Health SHA LLC Recruiting
Princeton, New Jersey, United States, 08540
Contact: Craig Rainbolt, Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02856646     History of Changes
Other Study ID Numbers: CA209-655
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases