RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Trial of Radiation Therapy With and Without Rituximab for Patients With Stage I II Follicular Lymphoma Grade I/II

Quick Facts

Study Start:2013-05-20

Study Completion:2027-05-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01473628

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Bouthaina S Dabaja

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Bouthaina S Dabaja, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-05-20

Study Completion Date2027-05-20

Study Record Updates

Study Start Date2013-05-20

Study Completion Date2027-05-20

Terms related to this study

Additional Relevant MeSH Terms

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