Scientists track follicular Lymphoma's evolution in untreated patients
NCT ID NCT03190928
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 9 times
Summary
This study aims to collect blood, tissue, and bone marrow samples from 200 adults with untreated follicular lymphoma. Researchers will monitor participants every 4 to 6 months for up to 5 years to track how the cancer changes and responds to treatment. The goal is to better understand the disease's biology to help design future therapies.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2017
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Up to 200 patients with pathologically-confirmed follicular lymphoma (grades 1-2, 3a) will be enrolled and screened for eligibility, and up to 80 eligible patients will receive active surveillance on this study for the purpose of expert monitoring of their disease, improved risk-stratification, and donation of tissue and cellular products for research.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Histologically or cytologically confirmed follicular lymphoma (FL), grades 1-2, or 3a confirmed by the Laboratory of Pathology, NCI; patients who meet criteria for immediate initiation of systemic therapy are eligible * Adequate tissue available from original diagnostic biopsy. NOTE: If biopsy was \>12 months prior to enrollment OR adequate tissue is not available, tissue biopsy may be optionally repeated unless such a biopsy is considered unacceptable risk to the patient. Patients without adequate tissue are eligible at the discretion of the PI. \- Must have disease that is measurable or evaluable on either computed tomography (CT) scans or FDG-positron emission tomography (FDG-PET) scans NOTE: Since patients with FL may have lesions that wax and wane on imaging, the requirement for disease being measurable or evaluable can come from imaging taken at any time at or after diagnosis, the most recent imaging prior to enrollment does not need to show measurable or evaluable disease. \- Age greater than or equal to 18 years NOTE: Patients with the pediatric-type follicular lymphoma are usually \<18 years of age, and often have a very different clinical course than patients with the adult-type of FL. Due to this difference in biology, children are excluded from this study. \- ECOG performance status \<2 (Karnofsky \>60%) EXCLUSION CRITERIA: * Previous history of diffuse large B-cell lymphoma or histologic transformation * Any prior systemic treatment for lymphoma including cytotoxic chemotherapy, biologic therapy, and monoclonal antibody therapy (radiotherapy permitted); patients who have received chemotherapy, biologic therapy, hormonal therapy, or monoclonal antibody for other malignancies are potentially eligible provided that all of the following are true: a) that malignancy was not lymphoma, b) systemic therapy ended at least 3 years prior to the diagnosis of FL, and c) there is no evidence of active malignancy other than FL NOTE: Initiation of first-line systemic therapy is allowed while on this trial; concurrent participation in first-line treatment clinical trials will be permitted. * Patients who are HIV-positive * Any second malignancy that requires active systemic therapy * Any other (non-lymphoma) life-threatening disease * Patients unable to provide informed consent (surrogates will not be used) * Pregnant women are excluded from enrollment onto this study because the invasive procedures and/or sedation needed to perform them may cause unnecessary harm to the unborn fetus. In the event a woman becomes pregnant while on study, she will not be removed from the study; however, no follow-up invasive clinical or research procedures will be done that include unacceptable to risk to the patient and/or to the unborn fetus.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new drug delay the need for lymphoma treatment?
- Can a single injection reprogram immune cells to fight cancer?
- Can a new immune cell therapy outsmart resistant blood cancers?
- Can a Triple-Drug combo wipe out Slow-Growing lymphomas?