Follicular Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01473628
First received: November 10, 2011
Last updated: April 14, 2014
Last verified: April 2014
  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.


Condition Intervention
Lymphoma
Drug: Rituximab
Radiation: Radiation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Radiation Therapy With and Without Rituximab for Patients With Stage I II Follicular Lymphoma Grade I/II

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: May 2013
Estimated Primary Completion Date: May 2027 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab + Radiation
Rituximab 375 mg/m2 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.
Drug: Rituximab

375 mg/m2 by vein every week for four consecutive weeks during the radiation treatment.

Maintenance: 375 mg/m2 by vein every 3 months for a total of 2 years.

Other Name: Rituxan
Radiation: Radiation
Total dose of 24 to 30 Gy over 12 to 15 treatments.
Other Names:
  • XRT
  • Radiation Therapy
Experimental: Radiation + Observation
Radiation therapy total dose of 24 to 30 Gy over 12 to 15 treatments.
Radiation: Radiation
Total dose of 24 to 30 Gy over 12 to 15 treatments.
Other Names:
  • XRT
  • Radiation Therapy

  Hide Detailed Description

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 3 ½-4 weeks (17 to 20 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, every week for 4 weeks during radiation therapy you will also receive rituximab by vein for up to 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.
  • You will have an ECG.
  • 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 years after rituximab treatment, every 6 months from Year 2 and beyond on and for up to 15 years. 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 height and 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 head, 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 height and 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 head, 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.
  • You will have an ECG.
  • 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 10 years.

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

Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: *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 two 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 two 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473628

Contacts
Contact: Bouthaina Dabaja, MD 713-563-2300

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Bouthaina Dabaja, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01473628     History of Changes
Other Study ID Numbers: 2011-0283, NCI-2012-00734
Study First Received: November 10, 2011
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
early stage follicular lymphoma
indolent non-Hodgkin's lymphomas
Lymphoma
Follicular Lymphoma
FL
Rituximab
Rituxan
Radiation
Radiation Therapy
XRT

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014