130 Participants Needed

Radiation Therapy + Rituximab for Follicular Lymphoma

Bouthaina S. Dabaja profile photo
Overseen ByBouthaina S. Dabaja
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 | MD Anderson ...

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

Absolute neutrophil count (ANC) >= 1000/mm^3; Platelets >= 80,000/mm^3; Hemoglobin >= 8 g/dL; Bilirubin =< 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) =< 2 times the ULN or aspartate aminotransferase (AST) =< 2 times the ULN; Performance status >= 2; Patients are required to have adequate renal function as indicated by a serum creatinine =< 2.5 mg/dL; 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
I have been newly diagnosed with early-stage follicular lymphoma, confirmed to be grade 1 or 2.
My doctor decides if I need lamivudine to prevent hepatitis B.

Exclusion Criteria

I have serious heart problems that need ongoing treatment.
I do not have any active infections needing treatment.
I've had radiation to the same area where my current cancer is, and can't have more without risking harm.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

4-6 months
12 radiation visits, 4-8 rituximab visits

Observation

Patients undergo observation after radiation therapy

2.5 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 years
Follow-up at 3 and 6 months, every 6 months for 2 years, yearly for 3 years, then every 2 years for 10 years

Treatment Details

Interventions

  • Radiation Therapy
  • Rituximab
Trial Overview The study tests the combination of radiation therapy with rituximab against cancer cells in patients with follicular lymphoma. Radiation aims to kill cancer cells directly while rituximab is an antibody that may help the immune system fight cancer.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm II (radiation therapy and observation)Experimental Treatment2 Interventions
Patients undergo radiation therapy five days a week for 2.5 weeks and then undergo observation.
Group II: Arm I (radiation therapy and rituximab)Experimental Treatment2 Interventions
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 Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇺🇸
Approved in United States as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇦
Approved in Canada as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇯🇵
Approved in Japan as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇳
Approved in China as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇭
Approved in Switzerland as Radiation Therapy for:
  • 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

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 94 patients with stage I-II follicular lymphoma, adding rituximab to radiation therapy improved 10-year progression-free survival (PFS) to 64.6% compared to 50.7% for radiation alone, suggesting enhanced treatment efficacy.
The study highlights the importance of molecular disease monitoring, as positive PCR results at diagnosis were linked to a higher risk of relapse, indicating that understanding the molecular profile of the disease can inform treatment strategies.
Addition of Rituximab to Involved-Field Radiation Therapy Prolongs Progression-free Survival in Stage I-II Follicular Lymphoma: Results of a Multicenter Study.Ruella, M., Filippi, AR., Bruna, R., et al.[2016]
Radioimmunotherapy (RIT) using (90)Y-ibritumomab tiuxetan or (131)I-tositumomab is effective for treating B-cell non-Hodgkin lymphoma, particularly in relapsed or refractory follicular lymphoma, with overall response rates of 60-80%.
RIT is generally safe, with reversible myelosuppression as the primary side effect, and it can enhance treatment outcomes when used as consolidation therapy after initial chemotherapy, improving response rates and prolonging disease control.
Treatment recommendations for radioimmunotherapy in follicular lymphoma: a consensus conference report.Witzig, TE., Fishkin, P., Gordon, LI., et al.[2019]
In a study of 41 early-stage follicular lymphoma patients treated with rituximab and involved-field radiotherapy, all patients achieved complete remission (CR), and the estimated 5-year progression-free survival (PFS) rate was 90%.
The combination of rituximab with involved-field radiotherapy appears to enhance treatment efficacy without increasing toxicity, suggesting it could be a promising first-line treatment option for early-stage follicular lymphoma.
Radiotherapy plus rituximab as first-line regimen for localized follicular lymphoma.Cencini, E., Puccini, B., Rigacci, L., et al.[2019]

References

Addition of Rituximab to Involved-Field Radiation Therapy Prolongs Progression-free Survival in Stage I-II Follicular Lymphoma: Results of a Multicenter Study. [2016]
Treatment recommendations for radioimmunotherapy in follicular lymphoma: a consensus conference report. [2019]
Radiotherapy plus rituximab as first-line regimen for localized follicular lymphoma. [2019]
Final results of a phase I radioimmunotherapy trial using (186)Re-epratuzumab for the treatment of patients with non-Hodgkin's lymphoma. [2017]
Phase II trial of short-course CHOP-R followed by 90Y-ibritumomab tiuxetan and extended rituximab in previously untreated follicular lymphoma. [2016]
Radioimmunotherapy for B-cell non-hodgkin lymphomas. [2022]
Radioimmunotherapy: a specific treatment protocol for cancer by cytotoxic radioisotopes conjugated to antibodies. [2019]
Combined radioimmunotherapy and radiotherapy of liver metastases from colorectal cancer: a feasibility study. [2018]
Radiation safety with yttrium 90 ibritumomab tiuxetan (Zevalin) radioimmunotherapy. [2019]
Radiotherapy for stage I/II follicular lymphoma (FL): is it time for a re-appraisal? [2014]
11.United Statespubmed.ncbi.nlm.nih.gov
Radiotherapy with rituximab may be better than radiotherapy alone in first-line treatment of early-stage follicular lymphoma: is it time to change the standard strategy? [2019]
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