This trial is evaluating whether Venetoclax will improve 1 primary outcome and 4 secondary outcomes in patients with Lymphoma, Mantle-Cell. Measurement will happen over the course of 8 months.
This trial requires 33 total participants across 2 different treatment groups
This trial involves 2 different treatments. Venetoclax 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 2 and have already been tested with other people.
About 3.8 million Americans are currently diagnosed lymphoma, mantle-cell in the Unites States. In our opinion our data suggest that a substantial number of people get mantle cell lymphomas during their lifetime.
Lymphoma, mantle-cell is a cancer of lymphocytes that originates in the lymphoid follicles, usually in the intestine, and generally manifests with extraintestinal lymphadenopathy as a disseminated form. Survival is prolonged in patients with mantle-cell lymphoma who undergo intensive chemotherapy before entering remission.
Almost all treatments for lymphoma can be grouped into 5 categories. You can find more information [with power(http://www.withpower.com/clinical-trials)] for each treatment by using [Power(http://www.withpower.com/clinical-trials)]. These categories provide doctors and patients with a common vocabulary to use when discussing treatments with the treatment plan.
Lymphoma, mantle-cell, cannot be cured. In most cases, patients may be well within 3 years, and in some cases within 8 years from diagnosis. Lymphoma, mantle-cell is a very poor prognosis. Treatment of lymphoma is challenging, as all patients require intensive management of their disease by physicians trained in both internal medicine and pathology.
A wide range of unexplained conditions, including swelling of the lymph nodes, fevers, and pain, are of unclear cause. Lymphadenopathy is the most common feature of lymphoma, and should be sought when lymphadenopathy is seen. There is little evidence to support the concept of 'atypical' lymphoid hyperplasia.
This is a rare type of non-Hodgkin's lymphoma, and the malignant plasma cells occur in lymphoid tissue and involve the paracortex and cortical mantle zones. Immunoglobulin class of IgG was found in the majority of cases, and a significant number of mantle-cell lymphomas had a chromosomal translocation t(11;18)(q21;q21) that is the hallmark of a subset of DLBCL, the translocation t(6;14)(p22;q32), also seen in ALCL. We suggest that mantle-cell lymphoma is a form of indolent lymphoma of the paracortex/cortical mantle zone.
Venetoclax administered at an initial dose of 200, 400, and 500 mg BID is well tolerated in people with good marrow function, including people with MM or WMML.
The FDA approved Venetoclax in January of 2009 for the treatment of relapsed or refractory [mantle cell lymphoma](https://www.withpower.com/clinical-trials/mantle-cell-lymphoma). Venetoclax was previously in clinical trials for relapsed/refractory Hodgkin lymphoma and relapsed/refractory non-Hodgkin's lymphoma. Patients are treated for 20 doses, and then on a day 28 withdrawal regimen. The average daily dose is 200 mg Venetoclax. [MedLine Plus] There are no published adverse event reports for venetoclax.
Although no specific side effects of venetoclax were found during clinical trials, safety data from patients enrolled in the aforementioned studies suggest that venetoclax is generally well tolerated, and the most common side effects, like nausea, vomiting, abdominal pain, diarrhea, fever, and dizziness, were mild or moderate. Further safety investigations are recommended to explore the unique side effects of venetoclax.
Lymphoma tends to spread slowly with time. This was likely the effect of the long latency of lymphoma. However, patients are still at risk for early spread and need to be monitored for disease-related complications from the disease.
Although much of the research into lymphoma treatment focuses on its treatment using new monoclonal antibody therapies, the advancement of research into targeted therapies for the disease is ongoing, with the most notable candidate being cemiplimab (Nelarabine), which is showing promise in a phase II trial in mantle-cell lymphoma. Lymphoma has been a highly studied disease with the advent of immunotherapy. Immunotherapy is a term that includes all types of cancer treatment that uses the body's own immune system to destroy cancer cells. Immunotherapy is categorized according to the type of cancer it treats by type of cancer stem-cells.
Clinical trials for lymphoma are difficult to find, but lymphoma clinical trials are not equally distributed. Lymphoma clinical trials are best accessed through Power or the NCI website, both of which specialize in finding clinical trials for lymphoma.