NCT01473628

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

Randomized Trial of Radiation Therapy With and Without Rituximab for Patients With Stage I II Follicular Lymphoma Grade I/II

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
OTHER	Clinical Observation	Undergo observation
RADIATION	Radiation Therapy	Undergo radiation therapy
BIOLOGICAL	Rituximab	Given IV

Timeline

• Start date: 2013-05-20
• Primary completion: 2027-05-20
• Completion: 2027-05-20
• First posted: 2011-11-17
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study