Recruiting

Observational Study

Sponsor:

Tempus AI

Code:

NCT07154823

Conditions

Acute Myeloid Leukaemia (AML)

Follicular Lymphoma ( FL)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

None - Observational Study

Study Details

Brief 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.

Conditions

Acute Myeloid Leukaemia (AML)

Follicular Lymphoma ( FL)

Study ID

NCT07154823

Start date

Jan 27, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2035

Anticipated

Primary completion date

Nov, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

550 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 001: Newly Diagnosed Acute Myeloid Leukemia (AML)

Newly diagnosed patients with a primary or secondary diagnosis of Acute Myeloid Leukemia (AML)

Cohort 002: Folicular Lymphoma

Cohort 002 contains four subgroups of Follicular Lymphoma (FL): A: Newly Diagnosed FL on Active Observation; B: Newly Diagnosed High Risk FL; C: Relapsed / Refractory High Risk POD24 FL; D: Transformed FL

Interventions

None - Observational Study

There are no interventions in this observational study.

Primary outcome measure

  • To assess biomarker landscape in the progression as well as baseline biospecimen samples and correlate with with real-world outcomes across multiple hematologic indications. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Aquarius Clinical Study Manager

800-739-4137aquarius@tempus.com

Locations

University of Iowa Hospital and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Principal Investigator:

Hira Shaikh, MD

The Center for Cancer and Blood Disorders

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

Principal Investigator:

Shreya Desai

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Emily Vukadinovic

scott.e@wustl.edu

Principal Investigator:

David Russler-Germain, MD

Cancer Care Specialists of Reno

Recruiting

Reno, Nevada, United States, 89511

Contacts

Principal Investigator:

Juan Adolfo Cattoni III

Novant Health Weisiger Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Principal Investigator:

James Dugan

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

Emily Curran

OhioHealth Research Institute

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Principal Investigator:

Bassem William

Taylor Cancer Research Center

Recruiting

Maumee, Ohio, United States, 43537

Contacts

Principal Investigator:

John Nemunaitis

Cancer Care Associates of York

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Principal Investigator:

Jackson Gao

Avera Cancer Institue

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Coordinator Contacts

ResearchAssistants@avera.org

Principal Investigator:

Waqas Jehangir

More Information

Sponsor

Tempus AI

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Hematologic Malignancy
  • Acute Myeloid Leukemia
  • AML
  • Next Generation Sequencing
  • NGS
  • Follicular Lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Tempus AI on 2026-09-02.