Lymphoma, Non-HodgkinLEONCT04996706
Evaluation of Lymphoma Prognosis and Survivorship in Recently Diagnosed Patients, LEO Study
An observational study of Lymphoma, Non-Hodgkin, run by Mayo Clinic at 12 sites in United States.
Trial summary
The goal of this infrastructure protocol is to build and maintain a large and diverse observational cohort study to support broad and cutting-edge research focused on NHL prognosis and survivorship. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- How many people
- 21,000 participants
- Where
- 12 sitesUnited States
- Study dates
- 16 Aug 2021to 31 Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 (NHL) willing to provide a research blood, saliva, stool, and/or tumor tissue sample, return enrollment and follow-up questionnaires, and allow access to medical records.
Who may be able to join
- Newly diagnosed within 6 months (180 days) of enrollment
- Patients may have been treated as long as initial non-Hodgkins Lymphoma (NHL) or Hodgkin's Lymphoma (HL) diagnosis is within 6 months of enrollment
- 18 years of age or older
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Emory St. Joseph's Hospital
Atlanta, Georgia, 30342
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
University of Miami: Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Weill Cornell Medical College
New York, New York, 10065
Mayo Clinic
Rochester, Minnesota, 55902
University of Rochester Medical Center
Rochester, New York, 14642
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
About this study
Official title: The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study Protocol
The goal of this infrastructure protocol is to build and maintain a large and diverse observational cohort study to support broad and cutting-edge research focused on NHL prognosis and survivorship. The LEO cohort will promote identification of clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors that impact multiple outcomes (including event-free, overall and lymphoma-specific survival; new onset comorbidities; and patient-reported outcomes). This resource also will allow examination of the interaction among these factors in order to better understand the clinical and molecular epidemiology of outcomes in NHL. Ultimately, this approach will drive discovery and validation of treatment endpoints, improve prognostication, and identify novel approaches to improve short and long-term outcomes for NHL patients.
Read the detailed description
- To extend recruitment at all 8 LEO centers as part of LEO2.0 using a single IRB, with a goal of recruiting an additional 8,000 newly diagnosed NHL patients (with funding from the NIH renewal grant to enroll 3,400) focused on Hispanic (N=900), African Americans (N=580), and Asian (N=200) participants (doubling the current sample size for these groups; adolescent and young adult patients age 18-39 years (N=870; 87% increase); and non-metro and rural patients of all ages and race/ethnicities (N=1,208, 72% increase) for a total cohort of over 21,000 patients;
- To review pathology at diagnosis and relapse of all LEO cases and maintain a central tumor bank for selected NHL subtypes that includes an H\&E slide, formalin-fixed, paraffin-embedded (FFPE) tissue samples in a tissue microarray (TMA), and extracted tumor DNA and RNA;
- To collect a peripheral blood sample and maintain a central biorepository of DNA, serum, plasma, and buffy coat;
- To continue to prospectively follow all participants in the LEO cohort to ascertain disease progression/relapse, retreatment, transformation, second cancers, survival (including cause of death), updated exposures, patient-reported outcomes (PROs), and other long-term health outcomes;
- To annotate and harmonize all cases with clinical, epidemiologic, pathology and treatment data, including development of new informatics enhancements to capture clinical data from electronic health records (EHRs), digital pathology, and radiology images, geocoded data from residence at diagnosis with linkage to public databases to enhance data on environmental exposures and socioeconomic factors; and
- Facilitate research projects that use this infrastructure, promote interactions with NCI-supported clinical trials networks, patient advocacy groups, and other collaborators, and to make the LEO resource accessible to patients and providers with publicly available risk calculators based on LEO data.
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- Lymphatic Diseases, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Immunoproliferative Disorders, Immune System Diseases
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphatic Diseases, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Immunoproliferative Disorders, Immune System Diseases
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: Time Frame: 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: Time Frame: 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: Time Frame: 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 posted9 Aug 2021
- Study start16 Aug 2021
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies 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
- 21,000 participants (estimated)
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, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James R Cerhan, MD,PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996706
- Sponsor's protocol ID
- 21-001804
- Other IDs
- U01CA195568, U01CA308978
- Acronym
- LEO
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2021
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of data can be requested through the LEO Cohort website.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study Protocol
- ClinicalTrials.gov ID
- NCT04996706
- Acronym / sponsor ID
- LEO / 21-001804
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- Lymphatic Diseases, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Immunoproliferative Disorders, Immune System Diseases
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 21,000 participants (estimated)
- 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, National Cancer Institute (NCI)
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 9 Aug 2021 (actual)
- 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 protocol is to build and maintain a large and diverse observational cohort study to support broad and cutting-edge research focused on NHL prognosis and survivorship. The LEO cohort will promote identification of clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors that impact multiple outcomes (including event-free, overall and lymphoma-specific survival; new onset comorbidities; and patient-reported outcomes). This resource also will allow examination of the interaction among these factors in order to better understand the clinical and molecular epidemiology of outcomes in NHL. Ultimately, this approach will drive discovery and validation of treatment endpoints, improve prognostication, and identify novel approaches to improve short and long-term outcomes for NHL patients.
Detailed description
- To extend recruitment at all 8 LEO centers as part of LEO2.0 using a single IRB, with a goal of recruiting an additional 8,000 newly diagnosed NHL patients (with funding from the NIH renewal grant to enroll 3,400) focused on Hispanic (N=900), African Americans (N=580), and Asian (N=200) participants (doubling the current sample size for these groups; adolescent and young adult patients age 18-39 years (N=870; 87% increase); and non-metro and rural patients of all ages and race/ethnicities (N=1,208, 72% increase) for a total cohort of over 21,000 patients;
- To review pathology at diagnosis and relapse of all LEO cases and maintain a central tumor bank for selected NHL subtypes that includes an H\&E slide, formalin-fixed, paraffin-embedded (FFPE) tissue samples in a tissue microarray (TMA), and extracted tumor DNA and RNA;
- To collect a peripheral blood sample and maintain a central biorepository of DNA, serum, plasma, and buffy coat;
- To continue to prospectively follow all participants in the LEO cohort to ascertain disease progression/relapse, retreatment, transformation, second cancers, survival (including cause of death), updated exposures, patient-reported outcomes (PROs), and other long-term health outcomes;
- To annotate and harmonize all cases with clinical, epidemiologic, pathology and treatment data, including development of new informatics enhancements to capture clinical data from electronic health records (EHRs), digital pathology, and radiology images, geocoded data from residence at diagnosis with linkage to public databases to enhance data on environmental exposures and socioeconomic factors; and
- Facilitate research projects that use this infrastructure, promote interactions with NCI-supported clinical trials networks, patient advocacy groups, and other collaborators, and to make the LEO resource accessible to patients and providers with publicly available risk calculators based on LEO data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 (NHL) willing to provide a research blood, saliva, stool, and/or tumor tissue sample, return enrollment and follow-up questionnaires, and allow access to medical records.
Key inclusion criteria (3 listed)
- Newly diagnosed within 6 months (180 days) of enrollment
- Patients may have been treated as long as initial non-Hodgkins Lymphoma (NHL) or Hodgkin's Lymphoma (HL) diagnosis is within 6 months of enrollment
- 18 years of age or older
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
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: 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: Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Lymphoma Specific Survival (LSS)
Time frame: Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Sharing of data can be requested through the LEO Cohort website.
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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.
James R Cerhan, MD,PhD principal investigator
Mayo Clinic
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Non-Hodgkin, run by Mayo Clinic at 12 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: enrolling by invitation, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
This study is still under way. Results are not available in the source record yet.
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: 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?
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 13 Jul 2026.