Clonal Evolution in Follicular Lymphoma

Therapuetic Areas:Oncology
Age Range:18 - 100
Start Date:July 27, 2017
End Date:July 1, 2025
Contact:Maureen E Edgerly, R.N.
Phone:(240) 760-6013

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Prospective Study of Clonal Evolution in Follicular Lymphoma


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.


To collect a variety of samples from people with follicular lymphoma to study how these
diseases progress and respond to treatment.


Adults at least 18 years old who have been diagnosed with, but have not yet had any treatment
for, follicular lymphoma.


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


- 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


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


- 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


- 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.


- 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

- 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%


- 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
We found this trial at
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 888-624-1937
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
Bethesda, MD
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