Ignite Creation Date:
2024-05-06 @ 10:12 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03190928
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2017-06-16
Brief Title:
Clonal Evolution in Follicular Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Prospective Study of Clonal Evolution in Follicular Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-10-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 17-C-0105 | None | None | None |