Radiation Therapy + Rituximab for Follicular Lymphoma
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
No Placebo Group
Breakthrough Therapy
Trial Summary
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.
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.
4791011Is 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.
13468What 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.
2451011Will 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.
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
I have been newly diagnosed with early-stage follicular lymphoma, confirmed to be grade 1 or 2.
Exclusion Criteria
I have serious heart problems that need ongoing treatment.
I've had radiation to the same area where my current cancer is, and can't have more without risking harm.
I have an active hepatitis B or C infection.
I am currently using alternative or complementary medicines.
Participant Groups
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.
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
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Combined radioimmunotherapy and radiotherapy of liver metastases from colorectal cancer: a feasibility study. [2018]A combination of radioimmunotherapy (RIT) and radiotherapy (RT) should allow one to increase the dose of radiation targeting a particular tumour without the concomitant increase of toxic side effects. This might be obtained if the dose limiting side effect of each individual radiation therapy concerned different organs.
Final results of a phase I radioimmunotherapy trial using (186)Re-epratuzumab for the treatment of patients with non-Hodgkin's lymphoma. [2017]Radioimmunotherapy (RIT) is an effective, new treatment modality for non-Hodgkin's lymphoma (NHL). The aim of this study was to determine the maximum tolerated dose and a first impression of the therapeutic potential of (186)Re-epratuzumab in patients with NHL.
Radiation safety with yttrium 90 ibritumomab tiuxetan (Zevalin) radioimmunotherapy. [2019]To present pertinent issues involved in radiation safety in radioimmunotherapy with 90Y ibritumomab tiuxetan.
Phase II trial of short-course CHOP-R followed by 90Y-ibritumomab tiuxetan and extended rituximab in previously untreated follicular lymphoma. [2016]Radioimmunotherapy has been approved for relapsed follicular lymphoma (FL), including rituximab-refractory FL. This study was designed to determine the CR rate with short-course chemoimmunotherapy with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (CHOP-R) followed by 90-Y ibritumomab tiuxetan (RIT) with extended rituximab as first-line treatment.
Treatment recommendations for radioimmunotherapy in follicular lymphoma: a consensus conference report. [2019]Radioimmunotherapy (RIT) with (90)Y-ibritumomab tiuxetan or (131)I-tositumomab combines a radiation-emitting radionuclide with an antibody targeting CD20 to treat B-cell non-Hodgkin lymphoma. Multiple studies demonstrate favorable RIT efficacy and safety profiles in follicular lymphoma (FL). The primary toxicity is reversible myelosuppression. Various FL treatment options include single-agent immunotherapy, radiation, chemoimmunotherapy, and RIT. Examining RIT clinical effects and position within treatment algorithms is important to optimal patient benefit. Clinical studies support using single-agent RIT in relapsed/refractory FL, in selected patients with new, untreated FL, and as consolidation after induction chemotherapy or chemoimmunotherapy. RIT as consolidation enhances response rates (with conversion of partial to complete responses following induction therapy) and prolongs disease control versus observation. The overall response rate is 60-80% in the relapsed setting. Time to progression is longer with low-bulk disease, fewer prior therapies, and retained rituximab sensitivity. RIT apparently does not preclude subsequent therapies or increase risk of secondary malignancies compared with chemotherapy's known risk. This article summarizes consensus recommendations for RIT and presents RIT treatment algorithms developed by hematologists/oncologists who regularly treat patients with FL. Maximizing RIT benefit requires healthcare providers to utilize algorithms assisting with treatment decisions.
Radioimmunotherapy for B-cell non-hodgkin lymphomas. [2022]Radioimmunotherapy (RIT) is a safe and effective therapeutic option for patients with indolent B-cell non-Hodgkin lymphomas (NHL), in both up-front and relapsed/refractory settings. Two approved agents (90Y-ibritumomab tiuxetan and 131I-tositumomab) are available in the United States. Both target CD20 with similar clinical outcomes but with unique clinical considerations and radiation precautions due to the use of varying radioisotopes.
Radiotherapy for stage I/II follicular lymphoma (FL): is it time for a re-appraisal? [2014]Almost 30% of follicular lymphomas (FL) present with stage I-II disease. Although the standard-of-care consists of involved-field radiotherapy (IFRT), approximately half of patients relapse usually outside the primary irradiation field. Systemic immunotherapy with rituximab (R), with or without IFRT, could reduce distant recurrences leading to a better outcome. Therefore, we compared the efficacy of IFRT-alone or associated with R (R+IFRT) versus R-alone in stage I/II FL (grade 1-3A).
Radioimmunotherapy: a specific treatment protocol for cancer by cytotoxic radioisotopes conjugated to antibodies. [2019]Radioimmunotherapy (RIT) represents a selective internal radiation therapy, that is, the use of radionuclides conjugated to tumor-directed monoclonal antibodies (including those fragments) or peptides. In a clinical field, two successful examples of this treatment protocol are currently extended by (90)Y-ibritumomab tiuxetan (Zevalin) and (131)I-tositumomab (Bexxar), both of which are anti-CD20 monoclonal antibodies coupled to cytotoxic radioisotopes and are approved for the treatment of non-Hodgkin lymphoma patients. In addition, some beneficial observations are obtained in preclinical studies targeting solid tumors. To date, in order to reduce the unnecessary exposure and to enhance the therapeutic efficacy, various biological, chemical, and treatment procedural improvements have been investigated in RIT. This review outlines the fundamentals of RIT and current knowledge of the preclinical/clinical trials for cancer treatment.
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]Early-stage follicular lymphoma (FL) has traditionally been treated with involved-field radiotherapy (RT). Rituximab (R) is a low-toxic, efficient systemic therapy for FL, but there are no data about its clinical impact in early FL. We retrospectively analyzed 93 patients with stage I-II indolent FL treated with RT (n=65) or RT+R (n=14) or R alone (n=14). Median follow-up was 5.0 years for patients with RT, 2.8 years for the RT+R subgroup and 2.5 years for patients treated with R. The complete response rate was 92%, 100% and 86% (not significant) and the median PFS was 3.3 years, not reached and 4.9 years (p=0.035) for the RT, RT+R and R arms, with no impact on overall survival. R combined with RT seems to give better results in terms of global FL control, but longer follow-up and prospective comparison are needed to verify these results.
Addition of Rituximab to Involved-Field Radiation Therapy Prolongs Progression-free Survival in Stage I-II Follicular Lymphoma: Results of a Multicenter Study. [2016]Rituximab (Rit) therapy added to involved-field radiation therapy (RT) has been proposed as an effective treatment for stage I-II follicular lymphoma (FL). The results of an observational multicenter study on the Rit-RT combination in limited-stage FL are here reported.
Radiotherapy plus rituximab as first-line regimen for localized follicular lymphoma. [2019]Early-stage follicular lymphoma (FL) can be cured with involved-field radiotherapy (IF-RT); however, many patients relapse in non-irradiated areas. A combined association with chemotherapy could increase treatment efficacy, but toxic effects could be unacceptable. In vitro synergistic effect between rituximab (R) and RT has been observed, but clinical data are limited. We retrospectively analyzed 41 early-stage FL patients receiving R and IF-RT as first-line treatment. We administered R 375mg/m2 weekly for four courses, before or after IF-RT (median dose 24 Gy). Primary outcome was PFS, secondary endpoints were CR rate, OS and safety. All patients achieved CR, after a median follow-up of 46 months only three patients relapsed after 18, 26 and 42 months; estimated 5-year PFS was 90%. We suggest R in association with IF-RT could represent a feasible first-line treatment option for early-stage FL and could increase efficacy without additional toxicity compared to available data about RT alone.