Randomized Trial of Radiation Therapy With and Without Rituximab for Patients With Stage I II Follicular Lymphoma Grade I/II
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival (PFS)
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.
10 years
No
Bouthaina Dabaja, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2011-0283
NCT01473628
May 2013
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |