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

NCT01473628 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2011-0283NCI-2012-00734
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 15 years

Secondary Outcomes (2)

• Overall survival

  Up to 15 years

• Progression free survival rate

  Up to 15 years

Study Arms (2)

Arm I (radiation therapy and rituximab)

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: Radiation Therapy; Biological: Rituximab

Arm II (radiation therapy and observation)

EXPERIMENTAL

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

Other: Clinical Observation; Radiation: Radiation Therapy

Interventions

Clinical Observation OTHER

Undergo observation

Also known as: observation

Arm II (radiation therapy and observation)

Radiation Therapy RADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Arm I (radiation therapy and rituximab); Arm II (radiation therapy and observation)

Rituximab BIOLOGICAL

Given IV

Also known as: 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

Arm I (radiation therapy and rituximab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Watchful Waiting; Observation; Radiotherapy; Radiation; Rituximab; CT-P10

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Methods; Investigative Techniques; Therapeutics; Physical Phenomena; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bouthaina S Dabaja

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 17, 2011
• Study Start: May 20, 2013
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)