Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN.
Hartmut Döhner, Andrew H Wei, Frederick R Appelbaum...
https://pubmed.ncbi.nlm.nih.gov/35797463Actively Recruiting
Age: 0Years +
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ID07154823
A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies
Led by Tempus AI · Updated on 2026-03-03
550
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting the TEMPUS AQUARIUS Study, a non-interventional, longitudinal observational study focused on patients with hematologic malignancies, specifically Acute Myeloid Leukemia (AML) and Follicular Lymphoma (FL). The study aims to collect detailed molecular and clinical data to better understand how biomarkers relate to real-world clinical outcomes in these diseases. This research is sponsored by Tempus AI and involves following patients over time to gather comprehensive information. Participants are grouped into cohorts, including newly diagnosed AML patients and four subgroups of FL patients: those on active observation, newly diagnosed high-risk patients, relapsed or refractory high-risk patients, and those with transformed FL. The study involves collecting serial blood samples and leftover tissue or bone marrow aspirates during routine care and disease monitoring. There are no treatment interventions as this is an observational study. Participants will be involved in regular biospecimen collection aligned with their standard therapy and monitoring schedules. Researchers will assess the biomarker landscape at baseline and throughout disease progression, correlating these findings with clinical outcomes over a five-year period. The study focuses on understanding disease biology and outcomes without altering participant treatment, and it will continue until November 2035.
CONDITIONS
Brief Title
A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies
Who Can Participate
Age: 0Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Willing and able to participate in the research and provide biospecimens
- Willing and able to provide informed consent
- Documented diagnosis of Acute Myeloid Leukemia (AML) according to WHO classification; secondary AML is allowed
- Histologically confirmed diagnosis of Follicular Lymphoma (FL) including subgroups: newly diagnosed on active observation, newly diagnosed high risk, relapsed/refractory high risk POD24, and transformed FL
- Submission of baseline sample representative of current disease for FL patients
- Specific criteria for FL subgroups regarding treatment status and risk assessments such as FLIPI, GELF, and LDH levels
You will not qualify if you...
- Not willing or able to adhere to study procedures
- Prior therapy intended for standard care treatment of AML in AML cohort
- For FL cohort: prior treatment for follicular lymphoma in active observation subgroup
- High risk follicular lymphoma diagnosis in active observation subgroup
- Resected patients with no evidence of disease in active observation subgroup
- FL patients intended for active observation in high risk subgroup
- Prior treatment for follicular lymphoma in high risk subgroup
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to confirm diagnosis and eligibility
Long-term Monitoring
Duration - Up to 5 years
Participants are observed over time to assess molecular biomarkers and correlate findings with real-world outcomes.
Periodic visits for biospecimen collection and assessments depending on cohort assignment
Trial Site Locations
Total: 5 locations
1
The Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
Actively Recruiting
2
Cancer Care Specialists of Reno
Reno, Nevada, United States, 89511
Actively Recruiting
3
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
4
Cancer Care Associates of York
York, Pennsylvania, United States, 17403
Actively Recruiting
5
Avera Cancer Institue
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
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Research Team
A
Aquarius Clinical Study Manager
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Genetic risk classification for adults with AML receiving less-intensive therapies: the 2024 ELN recommendations.
Hartmut Döhner, Courtney D DiNardo, Frederick R Appelbaum...
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https://pubmed.ncbi.nlm.nih.gov/33148933