Clonal Evolution in Follicular Lymphoma

Description

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.

Conditions

Follicular Lymphoma

Study Overview

Study Details

Study overview

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.

Prospective Study of Clonal Evolution in Follicular Lymphoma

Clonal Evolution in Follicular Lymphoma

Condition
Follicular Lymphoma
Intervention / Treatment

-

Contacts and Locations

Bethesda

National Institutes of Health Clinical Center, Bethesda, Maryland, United States, 20892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

National Cancer Institute (NCI),

Rahul Lakhotia, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

2029-01-01