Hodgkin's DiseaseNCT02856646
Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices
An observational study of Hodgkin's Disease, run by Bristol-Myers Squibb at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's Disease
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2016to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community Sample
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Hodgkin's Disease
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Population with Condition | Community Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to five years
Overall Survival (OS)
Measured: Up to five years
Progression Free Survival (PFS)
Measured: Up to five years
Duration of Response
Measured: Up to five years
Percentage of patients who achieve complete response
Measured: Up to 5 years
Percentage of patients who achieve partial response
Measured: Up to 5 years
Secondary outcomes (5)
Health-related quality of life (HRQoL)
Measured: Up to five years
Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Measured: Up to five years
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?
Measured: Up to five years
Healthcare resource utilization measured by imputed costs
Measured: Up to five years
Grade of AE
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start7 Oct 2016
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's DiseaseStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856646
- Sponsor's protocol ID
- CA209-655
- Status last verified
- Dec 2021
- First submitted
- 29 Jul 2016
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices
- ClinicalTrials.gov ID
- NCT02856646
- Acronym / sponsor ID
- CA209-655
- Conditions
- Hodgkin's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2016 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population with Condition | – | –Community Sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Overall Survival (OS)
Time frame: Up to five years
Progression Free Survival (PFS)
Time frame: Up to five years
Duration of Response
Time frame: Up to five years
Percentage of patients who achieve complete response
Time frame: Up to 5 years
Percentage of patients who achieve partial response
Time frame: Up to 5 years
5 secondary outcomes
Health-related quality of life (HRQoL)
Time frame: Up to five years
Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Time frame: Up to five years
Drivers of Treatment Choice
Time frame: Up to five years
Healthcare resource utilization measured by imputed costs
Time frame: Up to five years
Grade of AE
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin's Disease, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Treatment Patterns (time frame: Up to five years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.