Non-Hodgkin LymphomaLEONCT02736357
The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study
An observational study of Non-Hodgkin Lymphoma, run by Mayo Clinic at 8 sites in United States.
Trial summary
The goal of this infrastructure grant is to establish and maintain a cohort of over 12,000 non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research that identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Jul 2015to 17 Apr 2023
- How long will I take part?
- 20 Years
- 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: Newly diagnosed non-Hodgkin Lymphoma willing to provide a research blood sample, return enrollment and follow-up questionnaires, and allow access to medical records.
Who may be able to join
- Newly diagnosed non-Hodgkin Lymphoma (NHL), within 183 days of enrollment
- Patients may have been treated as long as initial NHL diagnosis is within 6 months of enrollment
- 18 years of age or older
Who cannot join
- Lymphoma diagnosis greater than 184 days from date of consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory University
Atlanta, Georgia, 30322
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Miami
Miami, Florida, 33136
Weill Cornell Medical College
New York, New York, 10021
Mayo Clinic
Rochester, Minnesota, 55902
University of Rochester
Rochester, New York, 14642
Washington University
St Louis, Missouri, 63130
About this study
The goal of this infrastructure grant is to establish and maintain a cohort of over 12,000 non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research that identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors, as well as the interaction among these factors, on short and long-term outcomes. These efforts will identify new approaches to improve the survival and well-being of NHL patients.
Read the detailed description
Newly diagnosed non-Hodgkin lymphoma (NHL) patients will be recruited from each center participating in the LEO cohort. At time of consent, participants will be asked to completed several questionnaires collecting health history, current medical and quality of life questions. Patients will also provide a baseline blood sample that will processed locally and stored centrally for future research use. Additionally, consent is given for use of excess clinical tumor tissue for research use.
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- Lymphoma, Cohort, non-Hodgkin
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from date of diagnosis to date of death
Measured: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Secondary outcomes (2)
Event Free Survival (EFS)
Time from date of diagnosis to date of first defined event (disease progression, relapse or re-treatment for lymphoma, or death)
Measured: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Lymphoma Specific Survival (LSS)
Time from date of diagnosis to date of death due to lymphoma
Measured: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start1 Jul 2015
- Primary completion17 Apr 2023
- Study completion17 Apr 2023
Why it stopped: Study restructured with Central IRB (NCT04996706); accruals reported there.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, University of Iowa, M.D. Anderson Cancer Center, Washington University School of Medicine, University of Rochester, Weill Medical College of Cornell University, University of Miami
- Responsible party
- Principal investigator, James Cerhan, Mayo Clinic
- Investigators
- James Cerhan, MD, PhD, Principal investigator, Mayo ClinicChristopher Flowers, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736357
- Sponsor's protocol ID
- 15-007282
- Acronym
- LEO
- Status last verified
- Jun 2023
- First submitted
- 4 Apr 2016
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available.
Publications
Ruan J, Chen Z, Larson MC, Bennani NN, Allen P, Mou E, Wallace D, Mehta-Shah N, Lossos IS, Malpica Castillo LE, Jaye DL, Vega F, Inghirami G, Pongas G, Akkad N, Casulo C, Martin P, Cohen JB, Habermann TM, Maurer MJ, Leonard JP, Friedberg JW, Kahl B, Cerhan JR, Flowers CR, Feldman AL. Patterns of care and clinical outcomes in systemic peripheral T-cell lymphoma: the LEO-MER prospective cohort study. Blood Adv. 2026 May 26;10(10):3480-3493. doi: 10.1182/bloodadvances.2025018455.
PubMed 41707114
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study
- ClinicalTrials.gov ID
- NCT02736357
- Acronym / sponsor ID
- LEO / 15-007282
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- Lymphoma, Cohort, non-Hodgkin
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study restructured with Central IRB (NCT04996706); accruals reported there.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Emory University, University of Iowa, M.D. Anderson Cancer Center, Washington University School of Medicine, University of Rochester, Weill Medical College of Cornell University, University of Miami
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 13 Apr 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 goal of this infrastructure grant is to establish and maintain a cohort of over 12,000 non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research that identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors, as well as the interaction among these factors, on short and long-term outcomes. These efforts will identify new approaches to improve the survival and well-being of NHL patients.
Detailed description
Newly diagnosed non-Hodgkin lymphoma (NHL) patients will be recruited from each center participating in the LEO cohort. At time of consent, participants will be asked to completed several questionnaires collecting health history, current medical and quality of life questions. Patients will also provide a baseline blood sample that will processed locally and stored centrally for future research use. Additionally, consent is given for use of excess clinical tumor tissue for research use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed non-Hodgkin Lymphoma willing to provide a research blood sample, return enrollment and follow-up questionnaires, and allow access to medical records.
Key inclusion criteria (3 listed)
- Newly diagnosed non-Hodgkin Lymphoma (NHL), within 183 days of enrollment
- Patients may have been treated as long as initial NHL diagnosis is within 6 months of enrollment
- 18 years of age or older
Key exclusion criteria (1 listed)
- Lymphoma diagnosis greater than 184 days from date of consent
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
Overall Survival (OS)
Time frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Time from date of diagnosis to date of death
2 secondary outcomes
Event Free Survival (EFS)
Time frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Lymphoma Specific Survival (LSS)
Time frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 41707114Ruan J, Chen Z, Larson MC, Bennani NN, Allen P, Mou E, Wallace D, Mehta-Shah N, Lossos IS, Malpica Castillo LE, Jaye DL, Vega F, Inghirami G, Pongas G, Akkad N, Casulo C, Martin P, Cohen JB, Habermann TM, Maurer MJ, Leonard JP, Friedberg JW, Kahl B, Cerhan JR, Flowers CR, Feldman AL. Patterns of care and clinical outcomes in systemic peripheral T-cell lymphoma: the LEO-MER prospective cohort study. Blood Adv. 2026 May 26;10(10):3480-3493. doi: 10.1182/bloodadvances.2025018455.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available.
Related trials for Non-Hodgkin Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
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.
James Cerhan, MD, PhD principal investigator
Mayo Clinic
Christopher Flowers, MD principal investigator
Emory University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin Lymphoma, run by Mayo Clinic at 8 sites 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Overall Survival (OS) (time frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02736357, which also lists 1 linked publication.
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 22 Jun 2023.