Longitudinal multi-center molecular biomarker registry for blood cancers

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

This registry will collect serial blood samples and leftover tissue from people with AML or follicular lymphoma to see if molecular biomarkers predict disease course and treatment outcomes.

Quick facts

• Study type: Observational
• Enrollment: 550 (estimated)
• Ages: 0 Years and up
• Sex: All
• Sponsor: Tempus AI (industry)
• Locations: 5 sites (Bethesda, Maryland and 4 other locations)
• Trial ID: NCT07154823 on ClinicalTrials.gov

What this trial studies

The TEMPUS AQUARIUS registry is a non-interventional, longitudinal, multi-center effort to collect paired molecular (multi-omic) and clinical data from patients with acute myeloid leukemia (AML) and follicular lymphoma. Participants provide serial blood draws and leftover tissue or bone marrow aspirates during routine care, and clinical outcomes are captured from medical records. Samples will undergo next-generation sequencing and other molecular analyses to link biomarkers with real-world outcomes. The registry does not change or prescribe treatment and is designed to build a large longitudinal dataset for biomarker discovery.

Who should consider this trial

Good fit: People with a documented diagnosis of AML or histologically confirmed follicular lymphoma who can provide informed consent and biospecimens during their routine care are ideal candidates.

Not a fit: Patients who cannot give consent, cannot provide serial samples, or who are seeking direct access to experimental therapies are unlikely to receive direct benefit from this observational registry.

Why it matters

Potential benefit: If successful, the registry could help clinicians predict prognosis and tailor treatment by identifying molecular biomarkers linked to outcomes.

How similar studies have performed: Prior genomic and biomarker registries in hematologic cancers have identified actionable mutations and prognostic signatures, but large longitudinal multi-omic registries like this are relatively novel.

Eligibility criteria

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

Where this trial is running

Bethesda, Maryland and 4 other locations

• The Center for Cancer and Blood Disorders — Bethesda, Maryland, United States (RECRUITING)
• Cancer Care Specialists of Reno — Reno, Nevada, United States (RECRUITING)
• Taylor Cancer Research Center — Maumee, Ohio, United States (RECRUITING)
• Cancer Care Associates of York — York, Pennsylvania, United States (RECRUITING)
• Avera Cancer Institue — Sioux Falls, South Dakota, United States (RECRUITING)

Study contacts

• Principal investigator: Michael Thompson, MD, PhD, FASCO — Tempus AI
• Study coordinator: Aquarius Clinical Study Manager

Conditions: Acute Myeloid Leukaemia, Follicular Lymphoma, Hematologic Malignancy, Acute Myeloid Leukemia, AML, Next Generation Sequencing, NGS