Follicular LymphomaNCT03190928
Clonal Evolution in Follicular Lymphoma
An observational study of Follicular Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2017to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Show all 9Show fewer
- 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%)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: Prospective Study of Clonal Evolution in Follicular Lymphoma
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.
Read more
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.
Read the detailed 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.
- Conditions
- Follicular Lymphoma
- Keywords
- Disease Monitoring, Molecular Monitoring, Novel Biomarker Identification, Gene Expression Analyses, Watchful-Waiting, Natural History
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with grades 1-2 or 3a follicular lymphoma (FL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ongoing
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.
Measured: 2 years
Secondary outcomes (5)
Progression-free survival
The number of days from initial diagnosis until date of first objective progression or death from any cause
Measured: 2 years
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
Measured: 5 years
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
Measured: 5 years
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
Measured: 5 years
Overall survival (OS)
The number of days from initial diagnosis until death from any cause
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start27 Jul 2017
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rahul Lakhotia, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190928
- Sponsor's protocol ID
- 170105
- Other IDs
- 17-C-0105
- Status last verified
- 13 Oct 2026
- First submitted
- 16 Jun 2017
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@All large scale genomic sequencing data will be shared with subscribers to dbGaP.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Clonal Evolution in Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT03190928
- Acronym / sponsor ID
- 170105
- Conditions
- Follicular Lymphoma
- Keywords
- Disease Monitoring, Molecular Monitoring, Novel Biomarker Identification, Gene Expression Analyses, Watchful-Waiting, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with grades 1-2 or 3a follicular lymphoma (FL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characteristics of treatment received (e.g., type, response, etc.) and molecular biology (e.g., pathology, histologic transformation) will be described
Time frame: ongoing
The types and frequency of each treatment will be reported.
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
Time frame: 2 years
Number of days from study enrollment until the date of initiation of first-line systemic treatment will be reported.
5 secondary outcomes
Progression-free survival
Time frame: 2 years
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
Time frame: 5 years
Progression-free survival from first active lymphoma treatment
Time frame: 5 years
Time to initiation of second-line systemic treatment
Time frame: 5 years
Overall survival (OS)
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@All large scale genomic sequencing data will be shared with subscribers to dbGaP.
Related trials for Follicular Lymphoma
Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
RecruitingPhase 3
Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma
Classic Follicular Lymphoma, Follicular Lymphoma With Unusual Cytological Features
RecruitingPhase 1
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
B-cell Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
Active, not recruitingPhase 3
A Long-term Extension Study of PCI-32765 (Ibrutinib)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma
Follicular Lymphoma, Marginal Zone Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rahul Lakhotia, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follicular Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NCI Medical Oncology Referral Office ((240) 760-6050, ncimo_referrals@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of treatment received (e.g., type, response, etc.) and molecular biology (e.g., pathology, histologic transformation) will be described (time frame: ongoing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.