Study on Radiation Therapy and Rituximab for Treating Stage I-II Grade 1 or Grade 2 Follicular Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01473628

Provider View

This clinical trial is exploring whether combining radiation therapy with the immunotherapy drug rituximab can better control stage I-II grade 1 or grade 2 follicular lymphoma compared to radiation therapy alone.

Patient Parameters

Program Overview

The study aims to find out if using radiation therapy together with rituximab, an immunotherapy drug, can more effectively kill cancer cells in patients with early-stage follicular lymphoma. Radiation therapy uses high-energy x-rays to destroy cancer cells, while rituximab helps the immune system attack the cancer and may prevent tumor growth and spread. The trial will compare the effectiveness of this combination treatment against radiation therapy alone.

Description

The main goal of this study is to see if adding rituximab to radiation therapy, followed by maintenance doses of rituximab, provides better outcomes than radiation therapy alone, specifically looking at how long patients remain free from cancer progression.

Participants in the study will be randomly assigned to one of two groups:

  • Group 1: Patients will receive radiation therapy five days a week for 2.5 weeks (12 treatments) and rituximab through an IV once a week for four weeks, starting with the radiation therapy. After that, they will receive rituximab every two months for up to four more doses, as long as the cancer does not progress and there are no severe side effects.

  • Group 2: Patients will receive radiation therapy five days a week for 2.5 weeks and then will be monitored without additional treatment.

After completing the treatment, patients will have follow-up visits at 3 and 6 months, every 6 months for 2 years, once a year for 3 years, and then every 2 years for 10 years to monitor their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with stage I or II follicular lymphoma, confirmed to be grade 1 or 2.
  • Must have certain blood counts and liver function within normal limits.
  • Must be in relatively good health with a performance status of 2 or better.
  • Must have adequate kidney function.
  • No known allergies to monoclonal antibodies.
  • Male participants must agree to use contraception or abstain from sex during the study.
  • Female participants must use two forms of contraception or abstain from sex, or be postmenopausal.
  • Female participants of childbearing potential must have a negative pregnancy test before starting rituximab.
  • Must be able to provide informed consent.

Exclusion Criteria

  • Active hepatitis B or C infection.
  • Known HIV infection.
  • Active infections requiring treatment.
  • Previous radiation to the current cancer site that would exceed safe limits.
  • Pre-existing heart disease requiring treatment, such as severe heart failure or recent heart attack.
  • Pregnant or breastfeeding women.
  • Use of alternative medicines.
  • Psychiatric or social conditions that would prevent following the study requirements.

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