RecruitingNCT07154823

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

Sponsor

Tempus AI

Enrollment

550 participants

Start Date

Jan 27, 2026

Study Type

OBSERVATIONAL

Conditions

Acute Myeloid Leukaemia (AML)Follicular Lymphoma ( FL)

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.

Eligibility

Min Age: 0 Years

Inclusion Criteria11

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

Exclusion Criteria9

\. 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