ClinicalTrials.gov
ClinicalTrials.gov Menu

Clonal Evolution in Follicular Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03190928
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.


Condition or disease
Follicular Lymphoma

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 Type : Observational
Estimated Enrollment : 88 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort
Patients
Patients with Follicular lymphoma (FL)



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Overall survival (OS), defined as the number of days from initialdiagnosis until death from any cause [ Time Frame: 10 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Up to 88 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.
Criteria
  • 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
  • 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%

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.

Information from the National Library of Medicine

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


Contacts
Contact: Maureen E Edgerly, R.N. (240) 760-6013 edgerlym@pbmac.nci.nih.gov

Locations
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      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mark J Roschewski, M.D. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03190928     History of Changes
Other Study ID Numbers: 170105
17-C-0105
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 4, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Disease Monitoring
Molecular Monitoring
Novel Biomarker Identification
Gene Expression Analyses
Watchful-Waiting

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin