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

NCT07154823 | Recruiting

• 1 other identifier: TP-CA-009
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 5

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Study Arms (2)

Cohort 001: Newly Diagnosed Acute Myeloid Leukemia (AML)

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

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

Other: None - Observational Study

Interventions

None - Observational Study OTHER

There are no interventions in this observational study.

Cohort 001: Newly Diagnosed Acute Myeloid Leukemia (AML); Cohort 002: Folicular Lymphoma

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is intended to include multiple hematologic malignancies.

You may qualify if:

• Willing and able to participate in the research and provide biospecimens
• Willing and able to provide informed consent
• Have documented diagnosis of AML according to the World Health Organization (WHO) classification
• Secondary AML is allowed
• Histologically confirmed diagnosis of Follicular Lymphoma (Subgroups A-D)
• Submission of baseline sample representative of current disease per laboratory manual (Subgroups A-D)
• A (Newly Diagnosed Active Observation): On active observation for 6 more or less, or intended for active observation
• B (Newly Diagnosed, High Risk): Intended for first line treatment
• B (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)
• C (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
• D (Transformed FL): Pathologically confirmed transformation

You may not qualify if:

• \. 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:
• A: Received prior treatment for follicular lymphoma
• A: Diagnosed with High Risk follicular lymphoma by any of the following definitions: FLIPI High Risk, GELF High Tumor Burden, LDH above ULN
• A: Resected patients with NED
• B: Intended for active observation
• B: Received prior treatment for follicular lymphoma

Sponsors & Collaborators

• Tempus AI: lead

Study Sites (5)

The Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

RECRUITING

Cancer Care Specialists of Reno

Reno, Nevada, 89511, United States

RECRUITING

Taylor Cancer Research Center

Maumee, Ohio, 43537, United States

RECRUITING

Cancer Care Associates of York

York, Pennsylvania, 17403, United States

RECRUITING

Avera Cancer Institue

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Related Publications (15)

• 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.

  PMID: 35797463 BACKGROUND

• Dohner 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.

  PMID: 39133932 BACKGROUND

• Charalampous 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.

  PMID: 37603349 BACKGROUND

• Kumar 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.

  PMID: 27511158 BACKGROUND

• Reed 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.

  PMID: 36454121 BACKGROUND

• Salam 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.

  PMID: 31892985 BACKGROUND

• Clara 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.

  PMID: 27807503 BACKGROUND

• Myers 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.

  PMID: 34156874 BACKGROUND

• Eichhorst 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.

  PMID: 27913474 BACKGROUND

• Kikushige 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.

  PMID: 33148933 BACKGROUND

• Thomas 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/

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 36796877 BACKGROUND

• Abbosh 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.

  PMID: 29968853 BACKGROUND

• Grayson 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/

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected at pre-specified baseline, follow-up and progression/recurrence or primary refractory disease timepoints. Leftover tissue and/or bone marrow aspirate may be collected depending on the indication of the cohort from standard of care procedures.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Lymphoma, Follicular; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site

Study Officials

• Michael Thompson, MD, PhD, FASCO

  Tempus AI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aquarius Clinical Study Manager

CONTACT

800-739-4137; aquarius@tempus.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 4, 2025
• Study Start: January 27, 2026
• Primary Completion (Estimated): November 1, 2034
• Study Completion (Estimated): November 1, 2035
• Last Updated: March 3, 2026

Record last verified: 2026-03

Locations

US (5)