Status:
NOT_YET_RECRUITING
A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies
Lead Sponsor:
Tempus AI
Conditions:
Acute Myeloid Leukaemia (AML)
Follicular Lymphoma ( FL)
Eligibility:
All Genders
Brief 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 co...
Eligibility Criteria
Inclusion
- All Cohorts
- 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
- 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
Key Trial Info
Start Date :
March 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2035
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT07154823
Start Date
March 1 2026
End Date
November 1 2035
Last Update
January 9 2026
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