Clonal Evolution in Follicular Lymphoma
ConditionFollicular Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)
About this trial
Background:
Follicular lymphoma is a type of cancer of the lymph nodes. Lab studies are important for cancer research. They help scientists better understand differences in the cancer biology of different patients. Researchers want to collect serial samples over time from people with follicular lymphoma to help them design future treatments.
Objective:
To collect a variety of samples from people with follicular lymphoma to study how these diseases progress and respond to treatment.
Eligibility:
Adults at least 18 years old who have been diagnosed with, but have not yet had any treatment for, follicular lymphoma.
Design:
Participants will be screened with medical history and physical exam. They will answer questions about daily functioning. They will have blood and urine tests. They may have scans and have tissue samples taken.
Participants will be monitored about every 4 months for up to 2 years. They will repeat screening tests. They will have a cheek swab. A small brush will be rubbed against the inside of the cheek to wipe off some cells.
Participants will have imaging scans about every 8 months for up to 2 years.
Participants may have a bone marrow aspiration and biopsy. The hipbone will be numbed with a small needle.
A needle will be put into the hipbone, and about 2 tablespoons of bone marrow will be taken out through the needle.
Participants will continue being monitored every 6 months for up to 5 years, then 1 time a year.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Patients who are HIV-positive
Any second malignancy that requires active systemic therapy
Trial design
Treatments tested in this trial
- Not listed
Trial groups
200 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov