Non-Hodgkin Lymphoma Sample Collection for MRD Testing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, observational study collects up to 60 mL of research blood and residual tumor tissue from adults with aggressive NHL to evaluate Natera's MRD assays. It aims to determine how well the ctDNA assay identifies minimal residual disease, monitors recurrence, and reflects treatment response after standard therapy. Participants are followed for up to three years, with blood samples at defined times during the first two years and data-only follow-up in the third year. No individual test results will be returned to participants or their clinicians. Tissue samples are obtained from procedures already performed as part of standard care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient is at least 18 years of age or older.
2. Eastern Cooperative Oncology Group performance status ≤ 2.
3. Patients who are able to consent to and provide residual tumor tissue for research. Bone marrow specimens are excluded as acceptable tumor tissue.
4. Patients with a new diagnosis of Stage I to IV aggressive non-Hodgkin lymphoma (NHL) including all aggressive large B-cell lymphoma (DLBCL, HGBCL, PMBCL), T-cell lymphoma (PTCL, ALCL), follicular lymphoma (FL) grade 3B, or transformed FL.
5. Patients who are planning to receive six cycles of first-line therapy with an anthracycline-based chemotherapy regimen as per the standard of care.
6. Radiographically measurable disease with at least one hypermetabolic lesion by Lugano classification on baseline FDG PET/CT or FDG PET (radiographically measurable disease by CT with intravenous contrast is allowed if FDG-PET/CT is not available).
7. Able to tolerate blood draws according to Natera standard process.

Exclusion Criteria:

1. Diagnosis of an indolent lymphoma that does not require immediate intervention, Hodgkin lymphoma, small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL). Other NHL diagnoses beyond DLBCL, aggressive TCLs, and grade 3B or transformed FL.
2. Diagnosis of aggressive NHL that has a circulating, leukemic component, bone marrow or blood involvement.
3. History of an allogeneic stem cell transplant or other organ transplant.
4. Prior history and treatment for any cancer within the past year or another active cancer, with the exception of participants who have undergone surgical removal of skin squamous cell or basal cell cancers.
5. Clinical ctDNA-MRD testing by any platform.
6. Concurrent treatment that includes an investigational agent.

Where it's running

• Natera, Inc.
  Austin, Texas, United States Recruiting

Study contacts

• Study coordinator: SCORE-NHL Study Team
• Email: contactscorenhlstudy@natera.com
• Phone: 650-489-9050

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.