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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None - Observational Study | Other | There are no interventions in this observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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All Cohorts Inclusion Criteria:
Cohort 001 Inclusion:
Cohort 002 Inclusion:
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:
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This study is intended to include multiple hematologic malignancies.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aquarius Clinical Study Manager | Contact | 800-739-4137 | aquarius@tempus.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Thompson, MD, PhD, FASCO | Tempus AI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Cancer and Blood Disorders | Recruiting | Bethesda | Maryland | 20817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35797463 | Background | 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. | |
| 39133932 |
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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.
| Cancer Care Specialists of Reno | Recruiting | Reno | Nevada | 89511 | United States |
|
| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45219 | United States |
|
| Taylor Cancer Research Center | Recruiting | Maumee | Ohio | 43537 | United States |
|
| Cancer Care Associates of York | Recruiting | York | Pennsylvania | 17403 | United States |
|
| Avera Cancer Institue | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
|
| 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. |
| 37603349 | 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. |
| 27511158 | 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. |
| 36454121 | 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. |
| 31892985 | 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. |
| 27807503 | 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. |
| 34156874 | 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. |
| 27913474 | 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. |
| 33148933 | 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. |
| 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 |
| 36796877 | 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. |
| 29968853 | 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. |
| 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/ |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D008224 | Lymphoma, Follicular |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
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