Evaluation of Lymphoma Prognosis and Survivorship in Recently Diagnosed Patients, LEO Study

• Conditions: Lymphoma, Non-Hodgkin

• Registration Number: NCT04996706
• Lead Sponsor: Mayo Clinic

Brief 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. 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

1. 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;

2. 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;

3. To collect a peripheral blood sample and maintain a central biorepository of DNA, serum, plasma, and buffy coat;

4. 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;

5. 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

6. 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 Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-09
• Study Start: 2021-08-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-27
• Last Update Posted: 2024-12-31
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 21000

Inclusion Criteria

• 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

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Exclusion Criteria

• Lymphoma diagnosis greater than 184 days from date of consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Lymphoma Specific Survival (LSS)	Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)	Time from date of diagnosis to date of death due to lymphoma
Event Free Survival (EFS)	Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)	Time from date of diagnosis to date of first defined event (disease progression, relapse or re-treatment for lymphoma, or death)

Trial Locations

Locations (10)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Washington University School of Medicine in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

University of Miami: Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Winship Cancer Institute of Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States