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

Tempus AI

Status: Enrolling

Conditions: Acute Myeloid Leukaemia (AML); Follicular Lymphoma ( FL)

Treatments: Other: None - Observational Study

Study type: Observational

Funder types: Industry

Identifiers

NCT07154823

TP-CA-009

Details and patient eligibility

About

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.

Enrollment: 550 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

All Cohorts Inclusion Criteria:

1. Willing and able to participate in the research and provide biospecimens
2. Willing and able to provide informed consent

Cohort 001 Inclusion:

1. Have documented diagnosis of AML according to the World Health Organization (WHO) classification
2. Secondary AML is allowed

Cohort 002 Inclusion:

1. Histologically confirmed diagnosis of Follicular Lymphoma (Subgroups A-D)
2. Submission of baseline sample representative of current disease per laboratory manual (Subgroups A-D)
3. 002A (Newly Diagnosed Active Observation): On active observation for 6 more or less, or intended for active observation
4. 002B (Newly Diagnosed, High Risk): Intended for first line treatment
5. 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)
6. 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
7. 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:

1. 002A: Received prior treatment for follicular lymphoma
2. 002A: Diagnosed with High Risk follicular lymphoma by any of the following definitions: FLIPI High Risk, GELF High Tumor Burden, LDH above ULN
3. 002A: Resected patients with NED
4. 002B: Intended for active observation
5. 002B: Received prior treatment for follicular lymphoma

Trial design

550 participants in 2 patient groups

Cohort 001: Newly Diagnosed Acute Myeloid Leukemia (AML)

Description:

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

Treatment:

Other: None - Observational Study

Cohort 002: Folicular Lymphoma

Description:

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

Treatment:

Other: None - Observational Study