Understanding the progression of follicular lymphoma

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 observational study aims to collect and analyze samples from adults diagnosed with follicular lymphoma who have not yet received treatment. Participants will undergo a series of medical evaluations, including blood and urine tests, imaging scans, and tissue sampling, over a period of up to two years. The goal is to characterize the molecular biology of the disease and monitor how it progresses, which may help in designing future treatments. By linking clinical information with biological data, researchers hope to identify potential therapeutic targets for patients at high risk of early disease progression.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:
* Histologically or cytologically confirmed follicular lymphoma (FL), grades 1-2, or 3a confirmed by the Laboratory of Pathology, NCI; individuals 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 individual. Individuals 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 individuals 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: Individuals with the pediatric-type follicular lymphoma are usually \<18 years of age, and often have a very different clinical course than individuals 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); individuals 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.

* Individuals who are HIV-positive
* Any second malignancy that requires active systemic therapy
* Any other (non-lymphoma) life-threatening disease
* Individuals 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 participant and/or to the unborn fetus.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Rahul Lakhotia, M.D. — National Cancer Institute (NCI)
• Study coordinator: NCI Medical Oncology Referral Office
• Email: ncimo_referrals@nih.gov
• Phone: (240) 760-6050

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Non-Hodgkin Lymphoma Sample Collection for MRD Testing

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• MK-1045 and Rituximab in Follicular Lymphoma

  This study tests whether adding MK-1045 to rituximab can help people with follicular lymphoma after standard therapy.

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• Mosunetuzumab and Zeprumetostat in Follicular Lymphoma

  This study tests whether a combination of Mosunetuzumab and Zeprumetostat can help adults with follicular lymphoma.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality and 1 other locations · NCT07555470

• Zanubrutinib plus obinutuzumab and lenalidomide for first-line follicular lymphoma

  This trial tests whether the combination of zanubrutinib, obinutuzumab, and lenalidomide is safe and effective as a chemotherapy-free first treatment for adults with untreated follicular lymphoma.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality and 1 other locations · NCT07299149

• LY4584180 with rituximab for adults with previously treated B‑cell lymphomas

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  Recruiting at 21 sites Phase 1 Eli Lilly and Company · Scottsdale, Arizona and 45 other locations · NCT07226843

• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

  This trial tests whether giving allogeneic NK cells with Rituximab, Tafasitamab, and IL-2 can help people with relapsed or refractory B-cell non-Hodgkin lymphoma who have tried at least two prior therapies.

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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.