Status:
RECRUITING
Radiation Therapy and Rituximab in Treating Patients With Stage I-II Grade 1 or Grade 2 Follicular Lymphoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ann Arbor Stage I Grade 1 Follicular Lymphoma
Ann Arbor Stage I Grade 2 Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
PRIMARY OBJECTIVE: I. To determine if rituximab concurrently with radiation followed by maintenance rituximab offers a superior benefit over radiation alone. Specifically looking at the progression f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2027
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01473628
Start Date
May 20 2013
End Date
May 20 2027
Last Update
November 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030