Clonal Evolution in Follicular Lymphoma

  • STATUS
    Recruiting
  • End date
    Jan 1, 2029
  • participants needed
    200
  • sponsor
    National Cancer Institute (NCI)
Updated on 7 May 2021
ct scan
cancer
follicular lymphoma
fludeoxyglucose f-18

Summary

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.

Description

Background
  • Follicular lymphoma (FL) is the second most common form of non-Hodgkin lymphoma and is incurable with standard first-line systemic therapy
  • The clinical course of FL varies from slowly progressive over many years to a more rapid disease course that requires therapy shortly after diagnosis
  • Early initiation of therapy does not improve survival, and asymptomatic patients are often managed with an initial period of watchful waiting
  • Clinical prognostic indices predict survival, but cannot predict outcome for individual patients; biologic-based classifiers (gene-expression profiling and somatic mutational analyses) are more robust than clinical indices, but require prospective clinical validation from the time of diagnosis in the modern treatment era
  • Paired samples linked to clinical information can lead to the discovery and/or validation of therapeutic targets for FL patients at the highest risk of early disease progression
    Objective

Characterize the molecular biology and clinical course of FL patients, and evaluate the time to treatment initiation for those patients who require first-line systemic therapy

Eligibility
  • Follicular lymphoma (grade 1-2, 3a) with no evidence of histological transformation
  • No previous cytotoxic, biologic or monoclonal antibody therapy for FL (previous radiation therapy permitted)
  • Age greater than or equal to 18 years
  • ECOG performance status of 0-2
Design
  • Patients with FL who meet all eligibility criteria will enroll on the study for expert monitoring of their disease, improved risk-stratification, and donation of tissue and cellular products for research. Patients will be monitored prospectively until they require second-line systemic treatment or the patient decides to withdraw from the study; untreated patients will be followed with clinic visits every 4 months for the first 2 years. After 2 years, protocol-specified visits will be increased to every 6 months until 5 years. After 5 years, protocol-specified visits will be annually until disease progression requiring first-line therapy.
  • Patients without an indication for first-line systemic therapy at 2 years from initial study enrollment will be offered an optional biopsy of their lymph node and bone marrow.
  • During first-line systemic therapy, patients can continue being monitored on this study for post-therapy clonal evolution. Protocol-specified visits after therapy will be every 6 months until 3 years. After 3 years, protocol-specified visits will be annually until disease progression requiring second-line therapy.
  • Upon initiation of second-line therapy, if applicable, patients will move to survival follow-up only.

Details
Condition Follicular Lymphoma, Lymphoma, Non-Hodgkin's Lymphoma
Clinical Study IdentifierNCT03190928
SponsorNational Cancer Institute (NCI)
Last Modified on7 May 2021

Eligibility

Yes No Not Sure

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 at study enrollment 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
Age greater than or equal to 18 years
NOTE: Patients with the pediatric-type follicular lymphoma are usually <18
the requirement for disease being measurable or evaluable can come from
years of age, and often have a very different clinical course than patients
imaging taken at any time at or after diagnosis, the most recent imaging prior
with the adult-type of FL. Due to this difference in biology, children are
to enrollment does not need
excluded from this study
to show measurable or evaluable disease
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 these 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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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