This trial is evaluating whether Gamitrinib will improve 1 primary outcome and 8 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of 7 years.
This trial requires 42 total participants across 7 different treatment groups
This trial involves 7 different treatments. Gamitrinib is the primary treatment being studied. Participants will be divided into 7 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
Approximately 70% of the world's adult population has lymphoma at some point in their life while less than ½ of them are diagnosed with the disease. This disease consists of 5 subtypes: (a) B cell lymphomas, (b) T cell lymphomas, (c) NK cell lymphomas, (c) plasma cell lymphomas and (c) mantle cell lymphomas. Patients of the latter two subtypes are generally at least 60 years of age, males are more often affected than females, and the most common type of lymphomas is the lymphoma not otherwise specified. Lymphomas are quite hard to treat; more than half of them are progressive, do not remit, and rarely respond to treatment.
The diagnosis of lymphoma is often made when the disease has been present for months and symptoms are unremarkable. The physical signs of lymphoma are non-specific so the diagnosis can delay treatment, especially if lymphoma has spread to the bone marrow. Patients with enlarged lymph nodes may need a test for human immunodeficiency Virus (HIV). The physical signs of Hodgkin's lymphoma include a diffuse bulging neck and upper chest pain. The main physical signs of non-Hodgkin's lymphoma are weight loss and anaemia. A bone scan is useful in confirming the extent and nature of metastasis. Pain is common in lymphoma and can be caused by malignancy.
There should be two rounds of therapy with chemotherapy and targeted therapy with immunotherapy in non-Hodgkin lymphoma. In Hodgkin lymphoma, two or three rounds of chemotherapy with radiotherapy and immunotherapy should be the rule in all cases of advanced Hodgkin lymphoma, but in initial and curative types of Hodgkin lymphoma, chemotherapy, including three or more rounds without radiotherapy should be the rule.
We conclude that the two factors which contribute most substantially to the development of lymphoma were (1) genetic predisposition and (2) environmental factors. The environmental factors acted to make the lymphoma cell more susceptible to the genetic predisposition. Thus, environmental factors, such as radiation, chemical, or viral exposure make the lymphoma cell more susceptible and, in some cases, the environmental factors promote and even cause lymphoma cell to take on the phenotype of a non-lysosomal membrane with antibody proteins attached to them, (‘lymphoma cells in “M” morphology’). In our opinion, it is this phenomenon which gives insight into the immunological processes involved in the development of lymphoma.
The cumulative incidence of lymphoma in the US population based on surveillance data is 1.21 per 10,000 population per year, with 2.3 new cases per 10,000 men and 1.7 in women per year. This implies that 1 in 20 men and 1 in 100 women are diagnosed with the disease. If these figures are representative of lymphoma as a whole, lymphoma accounts for more deaths in the US than in any other country. Because of differing incidence of lymphoma between various racial/ethnic groups, further epidemiological studies are needed to determine the contribution of these factors to cancer disparities in the US.
There is debate about the ability of lymphoma treatment to control the emergence of metastatic disease and to prevent cancer recurrence after a remission of the neoplasm. We need prospective randomized trials of the role of treatment strategy for eradicating relapsed disease in patients with high-grade diffuse and aggressive non-Hodgkin's lymphoma. summary: Findings from a recent study presents evidence that lymphoma may not be definitely cured by standard treatments for lymphoma, and that some people might develop a secondary lymphoma after initial remission of lymphoma. The authors discuss this dilemma and encourage the need for clinical trials of new treatment options against lymphoma.
Gamitrinib has been shown to be as effective as a placebo in a Phase III trial in patients with relapsed, refractory or relapsed acute lymphoblastic leukaemia or B-cell acute lymphoblastic leukaemia. The recommended dose of the drug was well tolerated. Gamitrinib is the first drug to receive U.S. FDA Committee of Review. Additional data will be obtained in the interim of the trial and submitted to FDA, and the Committee's recommendation will be reported at its meeting on 16 February 2017.
The current chemotherapy regimen is effective against all types of lymphoma. The advent of the B-lymphocyte-specific CD20-toxin (rituximab) was a major step in the chemotherapy for diffuse large B-cell lymphoma and the antibody therapy, with or without the tyrosine-kinase inhibitor, has been reported to be helpful against T cell acute lymphatic leukemia.. However, in recent years, the research on gene therapy, targeted therapies or immunotherapy for the treatment of lymphoma have been active including gene therapy, targeted therapies or immunotherapy for treating B-cell lymphomas such as FLT3 internal tandem duplication (c.
Gamitrinib is a selective, ATP-competitive mTOR inhibitor of the immunosuppressive class. It has single exposures that are not dependent on dosing, and produces robust antitumor effects in mouse models of non-Hodgkin's lymphoma. Results from a recent paper substantiate ongoing development of gamitrinib as a therapeutic for relapsed/refractory malignancies.
Lymphogranuloma venereum, Epstein Barr virus and Lymphomatoid granulomatosis are three lymphoma subtypes associated with the use of illicit drugs. In addition there is good evidence for the usefulness of treatment of some B cell chronic lymphoproliferative diseases by rituximab.\n\nThe most common sites of lymphoma are in the lymph organs that collect blood: the spleen, the lymph nodes (especially the central nervous system, bone marrow, and the lymph nodes), and the liver. Most common lymphoma types are diffuse B-cell lymphomas and T-cell lymphomas.
Gamitrinib is an oral small molecule inhibitor of the protein Aurora-B, which is overexpressed in many cancers and can promote cancer cell growth. Therefore, it appears that Aurora-B is a promising drug target for the treatment of both B-cell and T-cell lymphomas. There is also evidence that in human xenograft tumor models, knockdown of Aurora-B, using small interfering RNA-mediated knockdown, leads to an inhibited growth of many cancer cell types. Thus, Aurora-B might be useful in the treatment of both Hodgkin, and non-Hodgkin lymphoma.
Gamitrinib has a broad spectrum of activity in non-Hodgkin’s lymphoma, as demonstrated in both pre-clinical and clinical settings. Gamitrinib is also effective in acute myeloid progenitor cell leukaemia. Further studies to examine the efficacy of gamitrinib against both B- and T-cell lymphomas are warranted.