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

Overview

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.

Interventions

• Other None - Observational Study
  There are no interventions in this observational study.

Primary outcome measures

• 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]

Eligibility criteria

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:

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:

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 9 centers

• University of Iowa Hospital and Clinics — Iowa City
• The Center for Cancer and Blood Disorders — Bethesda
• Washington University in St. Louis — St Louis
• Cancer Care Specialists of Reno — Reno
• University of Cincinnati — Cincinnati
• OhioHealth Research Institute — Columbus
• Taylor Cancer Research Center — Maumee
• Cancer Care Associates of York — York
• … and 1 more center

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 S PMID 35797463
• 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;1 PMID 39133932
• 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 PMID 37603349
• 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, PMID 27511158
• 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
• 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
• 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
• 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-Expos PMID 34156874

Identifiers

NCT: NCT07154823 · TP-CA-009

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗