Radiation Therapy + Rituximab for Follicular Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have pre-existing cardiovascular disease requiring ongoing treatment, you may not be eligible to participate.
What data supports the effectiveness of the treatment Radiation Therapy + Rituximab for Follicular Lymphoma?
Research shows that adding Rituximab to radiation therapy can prolong the time patients with early-stage follicular lymphoma remain free from disease progression. Additionally, combining Rituximab with involved-field radiotherapy has resulted in high complete response rates and long progression-free survival in early-stage follicular lymphoma patients.12345
Is the combination of radiation therapy and rituximab generally safe for humans?
Radioimmunotherapy, which combines radiation with antibodies like rituximab, is considered a safe treatment option for certain types of non-Hodgkin lymphomas, including follicular lymphoma. Studies have shown that it can be used effectively with manageable safety precautions, although specific side effects and safety measures depend on the type of radioisotope used.56789
How does the treatment of radiation therapy combined with rituximab differ from other treatments for follicular lymphoma?
The combination of radiation therapy and rituximab for follicular lymphoma is unique because it combines local radiation with systemic immunotherapy, potentially reducing the risk of cancer returning outside the treated area. This approach may offer better control of the disease compared to radiation alone, with studies suggesting improved progression-free survival without additional toxicity.1351011
What is the purpose of this trial?
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.
Research Team
Bouthaina S. Dabaja
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for newly diagnosed patients with early-stage (I-II) grade 1 or 2 follicular lymphoma. Participants must have certain blood cell counts, good performance status, and proper liver and kidney function. Men must use contraception; women must be postmenopausal, surgically sterilized, or using two barrier methods of contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation and Rituximab Treatment
Patients undergo radiation therapy five days a week for 2.5 weeks and receive rituximab IV weekly for 4 weeks, followed by rituximab every 2 months for up to 4 additional doses
Observation
Patients undergo observation after radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Radiation Therapy
- Rituximab
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator