Understanding the progression of follicular lymphoma
Prospective Study of Clonal Evolution in Follicular Lymphoma
This study is trying to learn more about how follicular lymphoma develops in adults who haven't started treatment yet, by collecting samples and information to help find better treatments in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT03190928 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with follicular lymphoma but have not yet started any treatment.
Not a fit: Patients who have already received treatment for follicular lymphoma or those with transformed disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for patients with follicular lymphoma.
How similar studies have performed: While there have been studies on follicular lymphoma, this approach focusing on molecular characterization and monitoring in an observational setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.