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
This trial does not accept healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: 1
Trial outcomes
Primary outcomes
1
Characteristics of treatment received (e.g., type, response, etc.) and molecular biology (e.g., pathology, histologic transformation) will be described
The types and frequency of each treatment will be reported.
Time frame
ongoing2
Time to initiation of first-line systemic treatment (TTT1), defined as the number of days from study enrollment until the date of initiation of first-line systemic treatment
Number of days from study enrollment until the date of initiation of first-line systemic treatment will be reported.
Time frame
2 yearsSecondary outcomes
1
Progression-free survival
The number of days from initial diagnosis until date of first objective progression or death from any cause
Time frame
2 years2
Progression-free survival after first-line systemic treatment, defined as the number of days from diagnosis to objective disease progression after first-line systemic treatment
The number of days from diagnosis to objective disease progression after first-line systemic treatment or death from any cause
Time frame
5 years3
Progression-free survival from first active lymphoma treatment
The number of days from initiation of first-line systemic treatment to objective disease progression or death from any cause
Time frame
5 years4
Time to initiation of second-line systemic treatment
The number of days from study enrollment until the date of initiation of second-line systemic treatment
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov