Acute Myeloid Leukaemia (AML)AquariusNCT07154823
A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies
An observational study of Acute Myeloid Leukaemia (AML) and Follicular Lymphoma ( FL), run by Tempus AI at 13 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Acute Myeloid Leukaemia (AML), Follicular Lymphoma ( FL)
- What is being tested?
- None - Observational Study
- How many people
- 550 participants
- Where
- 13 sitesUnited States
- Study dates
- 27 Jan 2026to Nov 2035
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study is intended to include multiple hematologic malignancies.
All Cohorts Inclusion Criteria:
- Willing and able to participate in the research and provide biospecimens
- Willing and able to provide informed consent
Cohort 001 Inclusion:
- Have documented diagnosis of AML according to the World Health Organization (WHO) classification
- Secondary AML is allowed
Cohort 002 Inclusion:
- Histologically confirmed diagnosis of Follicular Lymphoma (Subgroups A-D)
- Submission of baseline sample representative of current disease per laboratory manual (Subgroups A-D)
- 002A (Newly Diagnosed Active Observation): On active observation for 6 more or less, or intended for active observation
- 002B (Newly Diagnosed, High Risk): Intended for first line treatment
- 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)
- 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
- 002D (Transformed FL): Pathologically confirmed transformation
All Cohorts Exclusion Criteria:
- Not willing or able to adhere with the study procedures
Cohort 001:
- Have received any prior therapy intended for standard of care (SoC) treatment of AML
Cohort 002:
- 002A: Received prior treatment for follicular lymphoma
- 002A: Diagnosed with High Risk follicular lymphoma by any of the following definitions: FLIPI High Risk, GELF High Tumor Burden, LDH above ULN
- 002A: Resected patients with NED
- 002B: Intended for active observation
- 002B: Received prior treatment for follicular lymphoma
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
The Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Kosunique Jenkins, 301-571-0019, ven.mdbet.KJenkins@aoncology.com
Shreya Desai
- Recruiting
Novant Health Weisiger Cancer Institute
Charlotte, North Carolina, 28204
Gait Jordan, pjordan@novanthealth.org
James Dugan
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
Bethany Fuhrman, 513-584-8162, fuhrmaba@ucmail.uc.edu
Emily Curran
- Recruiting
OhioHealth Research Institute
Columbus, Ohio, 43214
Kevin Miller, 614-788-3886, Kevin.Miller@ohiohealth.com
Bassem William
- Recruiting
Sanford Fargo
Fargo, North Dakota, 58104
Jamie Schmidt, 701-234-6848, jamie.schmidt@sanfordhealth.org
Seth Maliske, MD
- Recruiting
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
Herman Bernabe, hernan-bernabe@uiowa.edu
Hira Shaikh, MD
- Recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43537
Jennifer Martinez, 419-479-5605, JMartinez@tcrcpt.org
John Nemunaitis
- Recruiting
Cancer Care Specialists of Reno
Reno, Nevada, 89511
Layla Quinonez, 775-329-0222 ext. 230, ltapia@ccsreno.com
Juan Adolfo Cattoni III
- Recruiting
University of Rochester
Rochester, New York, 14627
Donald Burns, 585-275-2224, Donald_Burns@URMC.Rochester.edu
Carla Casulo, MD
- Recruiting
Avera Cancer Institue
Sioux Falls, South Dakota, 57105
Coordinator Contacts, ResearchAssistants@avera.org
Waqas Jehangir
- Recruiting
Sanford Sioux Falls
Sioux Falls, South Dakota, 57105
Michaela Melberg, 605-312-6229, michaela.melberg@sanfordhealth.org
Jonathan Bleeker, MD
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63130
Emily Vukadinovic, scott.e@wustl.edu
David Russler-Germain, MD
- Recruiting
Cancer Care Associates of York
York, Pennsylvania, 17403
Clarissa Vega, 717-741-9229, cvega@cancercareyork.com
Jackson Gao
About this study
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.
- Being tested
- None - Observational Study
- Keywords
- Hematologic Malignancy, Acute Myeloid Leukemia, AML, Next Generation Sequencing, NGS, Follicular Lymphoma
- Medical subject headings
- Leukemia, Myeloid, Acute, Lymphoma, Follicular, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - Observational StudyOther
There are no interventions in this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 001: Newly Diagnosed Acute Myeloid Leukemia (AML) | Newly diagnosed patients with a primary or secondary diagnosis of Acute Myeloid Leukemia (AML) Receives: Other: None - Observational Study | |
| 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 Receives: Other: None - Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess biomarker landscape in the progression as well as baseline biospecimen samples and correlate with with real-world outcomes across multiple hematologic indications.
The goal of this biomarker discovery registry is to assess DNA and RNA expression patterns and potential biomarkers in biospecimens collected at baseline and throughout treatment, with the goal of generating hypotheses about predictive markers for therapy selection, prognostic indicators, and potential mechanisms of resistance to standard-of-care therapies across multiple hematologic indications.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start27 Jan 2026
- Primary completionNov 2034 (estimated)
- Study completionNov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukaemia (AML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tempus AI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Thompson, MD, PhD, FASCO, Principal investigator, Tempus AI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154823
- Sponsor's protocol ID
- TP-CA-009
- Acronym
- Aquarius
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dohner H, Wei AH, Appelbaum FR, Craddock C, DiNardo CD, Dombret H, Ebert BL, Fenaux P, Godley LA, Hasserjian RP, Larson RA, Levine RL, Miyazaki Y, Niederwieser D, Ossenkoppele G, Rollig C, Sierra J, Stein EM, Tallman MS, Tien HF, Wang J, Wierzbowska A, Lowenberg B. Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN. Blood. 2022 Sep 22;140(12):1345-1377. doi: 10.1182/blood.2022016867.
PubMed 35797463Dohner H, DiNardo CD, Appelbaum FR, Craddock C, Dombret H, Ebert BL, Fenaux P, Godley LA, Hasserjian RP, Larson RA, Levine RL, Miyazaki Y, Niederwieser D, Ossenkoppele G, Rollig C, Sierra J, Stein EM, Tallman MS, Tien HF, Wang J, Wierzbowska A, Wei AH, Lowenberg B. Genetic risk classification for adults with AML receiving less-intensive therapies: the 2024 ELN recommendations. Blood. 2024 Nov 21;144(21):2169-2173. doi: 10.1182/blood.2024025409.
PubMed 39133932Charalampous C, Goel U, Kapoor P, Binder M, Buadi FK, Cook J, Dingli D, Dispenzieri A, Fonder AL, Gertz MA, Gonsalves W, Hayman SR, Hobbs MA, Hwa YL, Kourelis T, Lacy MQ, Leung N, Lin Y, Warsame R, Kyle RA, Rajkumar SV, Kumar SK. Outcomes of patients with primary refractory multiple myeloma in the era of triplet and quadruplet induction therapy. Blood Adv. 2023 Aug 22;7(16):4371-4380. doi: 10.1182/bloodadvances.2023009681.
PubMed 37603349Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016/S1470-2045(16)30206-6.
PubMed 27511158Reed SC, Croessmann S, Park BH. CHIP Happens: Clonal Hematopoiesis of Indeterminate Potential and Its Relationship to Solid Tumors. Clin Cancer Res. 2023 Apr 14;29(8):1403-1411. doi: 10.1158/1078-0432.CCR-22-2598.
PubMed 36454121Salam DSDA, Thit EE, Teoh SH, Tan SY, Peh SC, Cheah SC. C-MYC, BCL2 and BCL6 Translocation in B-cell Non-Hodgkin Lymphoma Cases. J Cancer. 2020 Jan 1;11(1):190-198. doi: 10.7150/jca.36954. eCollection 2020.
PubMed 31892985Clara JA, Sallman DA, Padron E. Clinical management of myelodysplastic syndrome/myeloproliferative neoplasm overlap syndromes. Cancer Biol Med. 2016 Sep;13(3):360-372. doi: 10.20892/j.issn.2095-3941.2016.0043.
PubMed 27807503Myers RM, Li Y, Barz Leahy A, Barrett DM, Teachey DT, Callahan C, Fasano CC, Rheingold SR, DiNofia A, Wray L, Aplenc R, Baniewicz D, Liu H, Shaw PA, Pequignot E, Getz KD, Brogdon JL, Fesnak AD, Siegel DL, Davis MM, Bartoszek C, Lacey SF, Hexner EO, Chew A, Wertheim GB, Levine BL, June CH, Grupp SA, Maude SL. Humanized CD19-Targeted Chimeric Antigen Receptor (CAR) T Cells in CAR-Naive and CAR-Exposed Children and Young Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia. J Clin Oncol. 2021 Sep 20;39(27):3044-3055. doi: 10.1200/JCO.20.03458. Epub 2021 Jun 22.
PubMed 34156874Eichhorst B, Hallek M. Prognostication of chronic lymphocytic leukemia in the era of new agents. Hematology Am Soc Hematol Educ Program. 2016 Dec 2;2016(1):149-155. doi: 10.1182/asheducation-2016.1.149.
PubMed 27913474Kikushige Y. Pathogenesis of chronic lymphocytic leukemia and the development of novel therapeutic strategies. J Clin Exp Hematop. 2020 Dec 15;60(4):146-158. doi: 10.3960/jslrt.20036. Epub 2020 Nov 4.
PubMed 33148933Thomas M. Pharma and the benefits of Real World Data. Drug Discovery World (DDW). Published November 4, 2021. Accessed May 5, 2023. https://www.ddw-online.com/trends-analysis-pharma-and-the-benefits-of-real-world-data-13702-202111/
Office of the Commissioner. Oncology Real World Evidence Program. U.S. Food and Drug Administration. Accessed May 5, 2023. https://www.fda.gov/about-fda/oncology-center-excellence/oncology-real-world-evidence-program
Vellanki PJ, Ghosh S, Pathak A, Fusco MJ, Bloomquist EW, Tang S, Singh H, Philip R, Pazdur R, Beaver JA. Regulatory implications of ctDNA in immuno-oncology for solid tumors. J Immunother Cancer. 2023 Feb;11(2):e005344. doi: 10.1136/jitc-2022-005344.
PubMed 36796877Abbosh C, Birkbak NJ, Swanton C. Early stage NSCLC - challenges to implementing ctDNA-based screening and MRD detection. Nat Rev Clin Oncol. 2018 Sep;15(9):577-586. doi: 10.1038/s41571-018-0058-3.
PubMed 29968853Grayson N. Real-world data can help make better drugs and do it faster. STAT. Published May 2, 2018. Accessed May 5, 2023. https://www.statnews.com/2018/05/02/real-world-data-drug-development/