Clonal Evolution in Follicular Lymphoma
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|ClinicalTrials.gov Identifier: NCT03190928|
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : May 23, 2018
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 year.
|Condition or disease|
- 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
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.
|Study Type :||Observational|
|Estimated Enrollment :||88 participants|
|Official Title:||Prospective Study of Clonal Evolution in Follicular Lymphoma|
|Actual Study Start Date :||July 27, 2017|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||July 1, 2025|
Patients with Follicular lymphoma (FL)
- 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 will be reported.
- Time to initiation of first-line systemic treatment (TTT1), definedas 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.
- Progression-free survival, defined as the number of days from initialdiagnosis until date of first objective progression or death from anycause [ Time Frame: 2 years ]
- Progression-free survival after firstline systemic treatment, defined asthe number of days from diagnosis to objective disease progressionafter first-line systemic treatment or death from any cause [ Time Frame: 5 years ]
- Progression-free survival from first active lymphoma treatment, defined as the number of days from initiation of first-line systemic treatment to objective disease progression or death from any cause [ Time Frame: 5 years ]
- Time to initiation of second-line systemic treatment, defined as thenumber of days from study enrollment until the date of initiationof second-line systemic treatment [ Time Frame: 5 years ]
- Overall survival (OS), defined as the number of days from initialdiagnosis until death from any cause [ Time Frame: 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190928
|Contact: Maureen E Edgerly, R.N.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Mark J Roschewski, M.D.||National Cancer Institute (NCI)|