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

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 130
• Participant gender: Both

Summary

The goal of this clinical research study is to learn if adding rituximab to radiation therapy will help control the disease better than radiation alone. The safety of this combination will also be studied.

Radiation therapy is designed to kill cancer cells or to stop cancer cells from growing.

Rituximab is designed to attach to cancer cells that have CD20 (a tumor marker) on their surface and damage them, which may cause the cells to die.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Rituximab
• Last Updated: 2016-10-04

Criteria

Inclusion Criteria:

1. Newly diagnosed patients with stage I and II follicular lymphoma, pathologically confirmed at MDACC to be grade 1 or 2.

2. Prophylactic use of lamivudine in patients that have antibody +, but no active infection will be up to the treating physician.

3. >/= 18 at the time of signing the informed consent form

4. Patients are required to have adequate bone marrow reserve as indicated: * Absolute neutrophil count (ANC) /=> 1000/mm^3 *Platelets >/= 80,000/mm^3, *Hemoglobin >/= 8g/dL. These values must be obtained within two weeks before protocol entry.

5. Patients must have adequate liver function as indicated by: *Bilirubinthe upper limit of normal (ULN), *Alanine transaminase (ALT)aspartate transaminase (AST)within two weeks before protocol entry. Performance status >/= 2

6. Patients are required to have adequate renal function as indicated by a serum creatinineprotocol entry.

7. No prior known allergic reaction to monoclonal antibodies.

8. Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.

9. 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).

10. Female patients of childbearing potential must have a negative serum pregnancy test (B HCG) within 72 hours of receiving the first dose of Rituximab

11. Patients must have the ability able to give informed consent.

Exclusion Criteria:

1. Patients with active Hepatitis B and/or Hepatitis C infection.

2. Patients with known HIV infection

3. Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.

4. 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.

5. Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes: a. Congestive heart failure III/IV as defined by New York Heart Association (NYHA) b. Uncontrolled cardiac arrhythmia, c. Unstable angina pectoris, d. Recent MI (within 6 months).

6. Patients who are pregnant or breast-feeding.

7. Patient with concurrent use of complementary or alternative medicines.

8. Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.