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.
Title
- Brief Title: Radiation Therapy and Rituximab in Treating Patients With Stage I-II Grade 1 or Grade 2 Follicular Lymphoma
- 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
- SECONDARY ID:
2011-0283
- SECONDARY ID:
P30CA016672
- NCT ID:
NCT01473628
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
Interventions
| Drug | Synonyms | Arms |
|---|
| Rituximab | ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab ABBS, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, rituximab biosimilar TQB2303, rituximab-abbs, RTXM83, Truxima | Radiation Therapy and Rituximab (Arm I) |
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.
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.
Detailed Description
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Radiation Therapy and Rituximab (Arm I) | Experimental | Patients undergo radiation therapy five days a week for 2.5 weeks (12 treatments) and receive rituximab IV over 4-6 hours weekly with the start of radiation for 4 weeks and then every 2 months for up to 4 additional doses in the absence of disease progression or unacceptable toxicity. | |
| Radiation Therapy and Observation (Arm II) | Experimental | Patients undergo radiation therapy five days a week for 2.5 weeks and then undergo observation. | |
Eligibility Criteria
Inclusion 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
- 18 at the time of signing the informed consent form
- 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
Exclusion Criteria:
- 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Proportion of patients that remain progression free, defined as progressive disease or death due to disease |
| Time Frame: | Up to 15 years |
| Safety Issue: | |
| Description: | The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between two different patient groups. The chi-square test or the Fisher's exact test will then be applied to assess the association between two categorical variables. Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate. Kaplan-Meier survival curves will also be constructed. |
Secondary Outcome Measures
| Measure: | Overall survival |
| Time Frame: | Up to 15 years |
| Safety Issue: | |
| Description: | Estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. The Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis. |
| Measure: | Progression free survival rate |
| Time Frame: | Up to 15 years |
| Safety Issue: | |
| Description: | Estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. The Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis. |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | M.D. Anderson Cancer Center |
Last Updated
March 13, 2020
