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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Clinical Observation — OTHER
  Undergo observation
• Radiation Therapy — RADIATION
  Undergo radiation therapy
• Rituximab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

May 20, 2013

Status verified

Feb 2026

Primary completion

May 20, 2027

Completion

May 20, 2027

Study Design

Enrollment

81 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (radiation therapy and rituximab)
  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.
• Experimental: Arm II (radiation therapy and observation)
  Patients undergo radiation therapy five days a week for 2.5 weeks and then undergo observation.

Primary Outcome Measure

Proportion of patients that remain progression free, defined as progressive disease or death due to disease [ Time Frame: Up to 15 years ]

Locations (1)

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