NCT01473628Active, not recruitingPhase 1/2
Radiation Therapy and Rituximab in Treating Patients With Stage I-II Grade 1 or Grade 2 Follicular Lymphoma
Randomized Trial of Radiation Therapy With and Without Rituximab for Patients With Stage I II Follicular Lymphoma Grade I/II
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- First submitted
- 10 Nov 2011
- Start date
- 20 May 2013
- Primary completion date
- 20 May 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Follicular lymphoma
- NCT number
- NCT01473628
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 81
- From 20 May 2013 to the primary completion date, 20 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Patient with concurrent use of complementary or alternative medicines
Other illness
- 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 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 with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements
Other
- Patients who are pregnant or breast-feeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.