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NCT07154823Recruiting

A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies

Tempus AI

Start Date

1/27/2026

Completion Date

11/1/2035

Summary

The TEMPUS AQUARIUS Study is a non-interventional, longitudinal observational study focused on hematological malignancies. It will collect rich molecular (multi-omic) and clinical data from patient cohorts through serial blood draws and the acquisition of leftover tissue and/or bone marrow aspirates during their routine therapy and disease monitoring. The primary goal is to understand the association between biomarkers and real-world clinical outcomes in these patient populations.

Eligibility Criteria

Age Range: No minimum to No maximum

All Cohorts Inclusion Criteria: 1. Willing and able to participate in the research and provide biospecimens 2. Willing and able to provide informed consent Cohort 001 Inclusion: 1. Have documented diagnosis of AML according to the World Health Organization (WHO) classification 2. Secondary AML is allowed Cohort 002 Inclusion: 1. Histologically confirmed diagnosis of Follicular Lymphoma (Subgroups A-D) 2. Submission of baseline sample representative of current disease per laboratory manual (Subgroups A-D) 3. 002A (Newly Diagnosed Active Observation): On active observation for 6 more or less, or intended for active observation 4. 002B (Newly Diagnosed, High Risk): Intended for first line treatment 5. 002B (Newly Diagnosed, High Risk): Meets the criteria for high risk by any of the following: Follicular Lymphoma Inernational Prognostic Index (FLIPI) High Risk, Groupe d'Etude des Lymphomes Follicularies (GELF) High Tumor Burden, Lactate Dehydrogenase (LDH) above the upper limit of normal (ULN) 6. 002C (Relapsed / Refractory High Risk POD24 FL): Documented progression of disease within 24 months (POD24) of first line follicular lymphoma treatment, prior to second line treatment 7. 002D (Transformed FL): Pathologically confirmed transformation All Cohorts Exclusion Criteria: 1\. Not willing or able to adhere with the study procedures Cohort 001: 1\. Have received any prior therapy intended for standard of care (SoC) treatment of AML Cohort 002: 1. 002A: Received prior treatment for follicular lymphoma 2. 002A: Diagnosed with High Risk follicular lymphoma by any of the following definitions: FLIPI High Risk, GELF High Tumor Burden, LDH above ULN 3. 002A: Resected patients with NED 4. 002B: Intended for active observation 5. 002B: Received prior treatment for follicular lymphoma

Interventions

OTHER

None - Observational Study

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Conditions

Acute Myeloid Leukaemia (AML)Follicular Lymphoma ( FL)

Locations

University of Iowa Hospital and Clinics

Iowa City, Iowa 52242

United States

The Center for Cancer and Blood Disorders

Bethesda, Maryland 20817

United States

Washington University in St. Louis

St Louis, Missouri 63130

United States

Cancer Care Specialists of Reno

Reno, Nevada 89511

United States

University of Cincinnati

Cincinnati, Ohio 45219

United States

OhioHealth Research Institute

Columbus, Ohio 43214

United States

Taylor Cancer Research Center

Maumee, Ohio 43537

United States

Cancer Care Associates of York

York, Pennsylvania 17403

United States

Avera Cancer Institue

Sioux Falls, South Dakota 57105

United States