Clinical Trials /

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

NCT01473628

Description:

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. This is an investigational study. Radiation and rituximab are FDA approved and commercially available for patients with lymphoma. Up to 130 patients will take part in this study. All will be enrolled at MD Anderson.

Related Conditions:
  • Follicular Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Randomized Trial of Radiation Therapy With and Without Rituximab for Patients With Stage I II Follicular Lymphoma Grade I/II
  • Official Title: Randomized Trial of Radiation Therapy With and Without Rituximab for Patients With Stage I II Follicular Lymphoma Grade I/II

Clinical Trial IDs

  • ORG STUDY ID: 2011-0283
  • SECONDARY ID: NCI-2012-00734
  • NCT ID: NCT01473628

Conditions

  • Lymphoma

Interventions

DrugSynonymsArms
RituximabRituxanRituximab + Radiation

Purpose

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.

Detailed Description

      Study Groups:

      If you are found to be eligible to take part in this study, you will be randomly assigned
      (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being in
      either group. This is done because no one knows if one study group is better, the same, or
      worse than the other group.

        -  If you are in Group 1, you will receive radiation alone.

        -  If you are in Group 2, you will receive radiation and rituximab.

      Radiation Therapy and Study Drug Administration:

      You will receive radiation therapy 5 days a week for 2 ½ weeks (12 treatments). You will
      receive a separate consent form that will describe this procedure and its risks in more
      detail.

      If you are in Group 2, you will receive rituximab every week for 4 weeks, beginning with the
      start of radiation therapy. You will receive rituximab by vein over 4-6 hours. After
      radiation therapy, you will continue to receive rituximab every 2 months for a total of 4
      doses.

      Study Visits During Radiation Therapy:

      Every week during radiation therapy:

        -  You will be asked about any drugs you may be taking.

        -  You will be asked how you are feeling and about any side effects you may be having.

        -  Your performance status will be recorded.

        -  You will have a physical exam.

      Study Visits After Completing Radiation Therapy:

      Every two months for a total of 4 doses (during rituximab-only therapy):

        -  You will be asked about any drugs you may be taking.

        -  Your performance status will be recorded.

        -  You will have a physical exam, including measurement of your height and weight.

        -  Blood (about 2 teaspoons) will be drawn for routine tests.

        -  You will be asked how you are feeling and about any side effects you may be having.

      Rituximab can be received outside MD Anderson as long as the outside doctor gives the drug
      in the same way.

      Routine Follow-up:

      You will also have routine follow-up visits every 3 months for the first 2 follow-up visits,
      every 6 months during the first 2 years, once a year during years 3 to 5 and every 2 years
      for years 5 to 15. At these visits, the following tests and procedures will be recorded:

        -  Your skin lesions will be photographed.

        -  You will be asked about any drugs you may be taking.

        -  You will be asked how you are feeling and about any side effects you may be having.

        -  Your performance status will be recorded.

        -  You will have a physical exam, including measurement of your weight.

        -  Blood (about 2 teaspoons) will be drawn for routine tests.

        -  You will have a PET scan to check the status of the disease.

        -  You will have CT scans of your neck, chest, abdomen, and pelvis.

      End-of-Study Drug Visits:

      If you leave the study early:

        -  Your skin lesions will be photographed.

        -  You will be asked about any drugs you may be taking.

        -  You will be asked how you are feeling and about any side effects you may be having.

        -  Your performance status will be recorded.

        -  You will have a physical exam, including measurement of your weight.

        -  Blood (about 2 teaspoons) will be drawn for routine tests.

        -  You will have a PET scan to check the status of the disease.

        -  You will have CT scans of your neck, chest, abdomen, and pelvis.

      Every 3 months for 2 years:

        -  You will be asked about any drugs you may be taking.

        -  You will be asked how you are feeling and about any side effects you may be having.

        -  Your performance status will be recorded.

        -  Blood (about 2 teaspoons) will be drawn for routine tests.

        -  If you are able to become pregnant, you will have a blood (about 2 teaspoons) pregnancy
           test.

      Length of Study:

      You will continue treatment for up to 4 doses of rituximab and/or up to 15 radiation
      treatments. You will no longer be able to take the study drug if the disease gets worse, if
      intolerable side effects occur, or if you are unable to follow study directions.

      You will be off study after up to 15 years.

      This is an investigational study. Radiation and rituximab are FDA approved and commercially
      available for patients with lymphoma.

      Up to 130 patients will take part in this study. All will be enrolled at MD Anderson.
    

Trial Arms

NameTypeDescriptionInterventions
Rituximab + RadiationExperimentalRituximab 375 mg/m^2 weekly for 4 weeks during radiation then every 3 months for 2 years (maintenance). Radiation therapy total dose of 24 to 30 Gy over 12 to 15 treatments.
  • Rituximab
Radiation + ObservationExperimentalRadiation therapy total dose of 24 to 30 Gy over 12 to 15 treatments.

    Eligibility 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 four weeks before protocol entry.
    
              5. Patients must have adequate liver function as indicated by: *Bilirubin </= 1.5 times
                 the upper limit of normal (ULN), *Alanine transaminase (ALT) </= 2 times the (ULN) or
                 aspartate transaminase (AST) </= 2 times the ULN, These values must be obtained
                 within four weeks before protocol entry. Performance status >/= 2
    
              6. 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.
    
              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.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Progression Free Survival (PFS)
    Time Frame:10 years
    Safety Issue:
    Description:Proportion of participants that remain progression free (PF) after 10 years from treatment initiation day, where progression is defined as progressive disease or death due to disease.

    Details

    Phase:Phase 1/Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:M.D. Anderson Cancer Center

    Trial Keywords

    • early stage follicular lymphoma
    • indolent non-Hodgkin's lymphomas
    • Lymphoma
    • Follicular Lymphoma
    • FL
    • Rituximab
    • Rituxan
    • Radiation
    • Radiation Therapy
    • XRT

    Last Updated

    April 18, 2017