A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies
Purpose
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)
Eligibility
- Eligible Ages
- Over 0 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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 |
|
Recruiting Locations
The Center for Cancer and Blood Disorders
Bethesda, Maryland 20817
Bethesda, Maryland 20817
Cancer Care Specialists of Reno
Reno, Nevada 89511
Reno, Nevada 89511
University of Cincinnati
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
OhioHealth Research Institute
Columbus, Ohio 43214
Columbus, Ohio 43214
Taylor Cancer Research Center
Maumee, Ohio 43537
Maumee, Ohio 43537
Cancer Care Associates of York
York, Pennsylvania 17403
York, Pennsylvania 17403
Avera Cancer Institue
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57105
More Details
- Status
- Recruiting
- Sponsor
- Tempus AI