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

Launched by M.D. ANDERSON CANCER CENTER · Nov 14, 2011

Keywords

ClinConnect Summary

This clinical trial is looking at how effective radiation therapy combined with a medication called rituximab is in treating patients with early-stage follicular lymphoma, which is a type of blood cancer. Radiation therapy uses high-energy X-rays to kill cancer cells, while rituximab helps the immune system fight the cancer. The goal of the study is to see if using both treatments together can improve outcomes for patients with this type of lymphoma.

To participate in the trial, patients need to be newly diagnosed with stage I or II follicular lymphoma, confirmed by doctors at MD Anderson Cancer Center. They should also meet certain health criteria, such as having adequate blood counts and kidney function. Participants can expect to receive both radiation therapy and rituximab during the study, and their progress will be closely monitored. This trial is currently recruiting patients, and it’s important for potential participants to discuss any health conditions or medications with their doctor to ensure they meet the eligibility requirements.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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