Radiation Therapy and Rituximab in Treating Patients With Stage I-II Grade 1 or Grade 2 Follicular Lymphoma

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Ann Arbor Stage I Grade 1 Follicular Lymphoma, Ann Arbor Stage I Grade 2 Follicular Lymphoma, Ann Arbor Stage II Grade 1 Follicular Lymphoma, Ann Arbor Stage II Grade 2 Follicular Lymphoma

In brief

This randomized phase I/II trial studies radiation therapy and rituximab in treating patients with stage I-II grade 1 or grade 2 follicular lymphoma. Radiation therapy uses high energy x-rays to kill cancer cells. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy with rituximab may kill more cancer cells.

Key facts

Study ID: NCT01473628
Run by: M.D. Anderson Cancer Center
People needed: 81
Starts: 2013-05-20
Expected to finish: 2027-05-20
Last updated by the study team: 2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Newly diagnosed patients with stage I and II follicular lymphoma, pathologically confirmed at MD Anderson Cancer Center (MDACC) to be grade 1 or 2
Prophylactic use of lamivudine in patients that have antibody positive (+), but no active infection will be up to the treating physician
Absolute neutrophil count (ANC) >= 1000/mm\^3; this value must be obtained within four weeks before protocol entry
Platelets >= 80,000/mm\^3; this value must be obtained within four weeks before protocol entry
Hemoglobin >= 8 g/dL; this value must be obtained within four weeks before protocol entry
Bilirubin =< 1.5 times the upper limit of normal (ULN); this value must be obtained within four weeks before protocol entry
Alanine aminotransferase (ALT) =< 2 times the ULN or aspartate aminotransferase (AST) =< 2 times the ULN; these values must be obtained within four weeks before protocol entry
Performance status >= 2
Patients are required to have adequate renal function as indicated by a serum creatinine =< 2.5 mg/dL; this value must be obtained within four weeks before protocol entry
No prior known allergic reaction to monoclonal antibodies
Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study
Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized)
Female patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [B HCG]) within 72 hours of receiving the first dose of rituximab
Patients must have the ability able to give informed consent

You may not qualify if…

Patients with active hepatitis B and/or hepatitis C infection
Patients with known human immunodeficiency virus (HIV) infection
Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved
Patients who had previous radiation dose to the site of the current primary disease, which would lead to violation of known radiation tolerance limit of that particular site if treated again
Patients with pre-existing cardiovascular disease requiring ongoing treatment; this includes: congestive heart failure III/IV as defined by New York Heart Association (NYHA); uncontrolled cardiac arrhythmia; unstable angina pectoris; and recent myocardial infarction (MI) (within 6 months)
Patients who are pregnant or breast-feeding
Patient with concurrent use of complementary or alternative medicines
Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.