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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
0 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The TEMPUS AQUARIUS Study looks at signs in blood and tissue that may be linked to how blood cancers respond to care. It is for people with acute myeloid leukemia (AML) or follicular lymphoma. The study does not assign treatment; it collects blood over time, health data, and leftover tissue or bone marrow samples from routine care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All groups: You must agree to join, give study samples, and give informed consent.
  • AML group: You must have a confirmed AML diagnosis that meets World Health Organization rules. AML that developed from another condition is allowed.
  • All follicular lymphoma groups: A tissue test must confirm this cancer. You must provide a starting sample that shows your current disease.
  • Group 002A: You must be newly diagnosed and being watched without treatment, or plan to be watched without treatment.
  • Group 002B: You must plan to start your first treatment and have high-risk disease based on a FLIPI risk score, GELF rules for cancer amount, or a high LDH blood test result.
  • Group 002C: Your lymphoma must have worsened within 24 months of your first treatment. You must not yet have started your second treatment.
  • Group 002D: A tissue test must show that your follicular lymphoma has changed into another form.

Who can't join

  • All groups: You cannot join if you are unwilling or unable to follow study steps.
  • AML group: You cannot join if you have already received treatment meant as standard care for AML.
  • Group 002A: You cannot join if you have had treatment for follicular lymphoma.
  • Group 002A: You cannot join if you have high-risk disease based on a FLIPI risk score, GELF rules for cancer amount, or a high LDH blood test result.
  • Group 002A: You cannot join if your cancer was removed by surgery and there is no sign of disease.
  • Group 002B: You cannot join if you plan to be watched without treatment or have already had treatment for follicular lymphoma.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (13)

IA

MD

MO

NC

ND

NV

NY

OH

PA

SD