This trial is evaluating whether Obinutuzumab will improve 1 primary outcome and 10 secondary outcomes in patients with Lymphoma, Follicular. Measurement will happen over the course of From infusion to onset of IRR during Cycle 2 (1 cycle: 21 or 28 days depending on the chemotherapy selected).
This trial requires 114 total participants across 2 different treatment groups
This trial involves 2 different treatments. Obinutuzumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
Lymphoma, follicular symptoms of a cough or a decreased rate of breathing can suggest the diagnosis of lymphoma, follicular. Furthermore, because of the variability in presentation of lymphoma, a history of exposure to infectious, occupational or environmental agents is very useful in aiding diagnosis.\n
In the majority of cases, lymphoma is caused by the proliferation of a cell in lymphatics. Most cases of lymphoma may be diagnosed due to the development of new symptoms, rather than the presence of a tumor. Risk factors that enhance the incidence or advancement of lymphoma include increased age, a history of viral infections, immunodeficiency states, and family history of cancer. Lymphoma can be caused from a viral infection such as a hepatitis virus or a parvovirus. The development of lymphoma may be related to hepatitis B virus or hepatitis C virus infections, immunodeficiency states, and genetic factors.
Treatments include radiation therapy, chemotherapy, and/or watchful waiting. Treatments may be prescribed to patients with asymptomatic lymphomas. Many patients with lymphoma also have chronic diseases. Treatment may be prescribed or recommended for such conditions.
Lymphoma (especially [follicular lymphoma](https://www.withpower.com/clinical-trials/follicular-lymphoma)) can be cured in large part. Many patients will remain free of symptoms for years. The disease will not reoccur; however the possibility that residual disease existed before the therapy exists. Patients with relapsing disease, more advanced stage, and high risk features should continue therapy for a full course to eradicate disease and prevent recurrence. Patients who are cured, however, are often free of symptoms with minimal medication.
The American Cancer Society estimated that there are 23,950 new lymphoma, follicular cases that will be diagnosed in the year 2016, making it the 6th most common cancer among women. These numbers are still highly debated within the scientific literature, because most people do not seek a medical examination in cases in which symptoms are present.
The vast majority of primary MALT lymphomas arise in the small intestine; they are often associated with chronic intestinal infection. The follicular lymphomas of MALT are generally a chronic condition. They most commonly occur in people older than 50.\n
Data from a recent study is valuable because it provides information on the likelihood of lymphoma treatment outcome and how it may be predicted using clinical and histopathologic factors.
Recent findings suggest that obinutuzumab does not significantly improve EFS, PFS or OS when used on its own as an induction agent for follicular lymphoma, but may improve OS when used in combination with brentuximab vedotin or rituximab.
The FDA granted a pivotal path to OBIN for the initial treatment of CLL. This trial had the longest ever randomized assessment of treatment duration and outcomes in CLL patients. Based on these data and additional Phase 3 studies, the FDA granted a label change to shorten treatment to 12 weeks for all patients. Additional clinical trials are currently underway after this change. The FDA was able to use the 12-week duration as a surrogate and indicator for the longer duration. This is important with CLL. The 12-week treatment time point has been used to gauge the success of the treatment which should assure compliance. Based on these trials, it should be reasonable to expect treatment duration to be progressively shorter.
Patients with [follicular lymphoma](https://www.withpower.com/clinical-trials/follicular-lymphoma) have the same 5-year survival rates as those with diffuse-type follicular lymphoma. These survival rates are similar to reports for other types of lymphoma. Because there is no difference in progression-free survival, the 5-year progression-free survival rate of patients with low-grade follicular lymphoma is also similar to the rest of the lymphoma population.
Obincutuzumab improved QoL in patients with follicular NHL after a median follow up of 24.5 months, with a trend toward improvement in QoL at 12 months. The efficacy of obinutuzumab did not correlate with prior treatment.