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

Primary Purpose

Ann Arbor Stage I Grade 1 Follicular Lymphoma, Ann Arbor Stage I Grade 2 Follicular Lymphoma, Ann Arbor Stage II Grade 1 Follicular Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Clinical Observation
Radiation Therapy
Rituximab
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ann Arbor Stage I Grade 1 Follicular Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (radiation therapy and rituximab)

Arm II (radiation therapy and observation)

Arm Description

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.

Patients undergo radiation therapy five days a week for 2.5 weeks and then undergo observation.

Outcomes

Primary Outcome Measures

Proportion of patients that remain progression free, defined as progressive disease or death due to disease
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

Overall survival
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.
Progression free survival rate
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.

Full Information

First Posted
November 10, 2011
Last Updated
June 6, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01473628
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2013 (Actual)
Primary Completion Date
May 20, 2027 (Anticipated)
Study Completion Date
May 20, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized phase I/II trial studies radiation therapy and rituximab in treating patients with stage I-II grade 1 or grade 2 follicular lymphoma. Radiation therapy uses high energy x-rays to kill cancer cells. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy with rituximab may kill more cancer cells.
Detailed Description
PRIMARY OBJECTIVE: I. To determine if rituximab concurrently with radiation followed by maintenance rituximab offers a superior benefit over radiation alone. Specifically looking at the progression free survival. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo radiation therapy five days a week for 2.5 weeks (12 treatments) and receive rituximab intravenously (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. ARM II: Patients undergo radiation therapy five days a week for 2.5 weeks and then undergo observation. After completion of study treatment, patients are followed up at 3 and 6 months, every 6 months for 2 years, yearly for 3 years, and then every 2 years for 10 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (radiation therapy and rituximab)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (radiation therapy and observation)
Arm Type
Experimental
Arm Description
Patients undergo radiation therapy five days a week for 2.5 weeks and then undergo observation.
Intervention Type
Other
Intervention Name(s)
Clinical Observation
Other Intervention Name(s)
observation
Intervention Description
Undergo observation
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo radiation therapy
Intervention Type
Biological
Intervention Name(s)
Rituximab
Other Intervention Name(s)
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, Riabni, Rituxan, Rituximab ABBS, Rituximab ARRX, 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 SIBP-02, rituximab biosimilar TQB2303, Rituximab PVVR, rituximab-abbs, Rituximab-arrx, Rituximab-pvvr, RTXM83, Ruxience, Truxima
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Proportion of patients that remain progression free, defined as progressive disease or death due to disease
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.
Time Frame
Up to 15 years
Secondary Outcome Measure Information:
Title
Overall survival
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.
Time Frame
Up to 15 years
Title
Progression free survival rate
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.
Time Frame
Up to 15 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bouthaina S Dabaja
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bouthaina S. Dabaja
Phone
713-563-2300
Email
bdabaja@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Bouthaina S. Dabaja

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

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

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