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
Washington University in St. Louis and nearby locations
Washington University in St. Louis
St Louis, Missouri 63130
St Louis, Missouri 63130
More Details
- NCT ID
- NCT07154823
- Status
- Recruiting
- Sponsor
- Tempus AI