This trial is evaluating whether Gilteritinib will improve 1 primary outcome and 3 secondary outcomes in patients with Leukemia, Myeloid. Measurement will happen over the course of Up to 18 months.
This trial requires 22 total participants across 2 different treatment groups
This trial involves 2 different treatments. Gilteritinib is the primary treatment being studied. Participants will be divided into 2 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.
"Gilteritinib is an inhibitor of the FGFRs1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, and 24, which are tyrosine kinase receptors involved in cell proliferation, survival, angiogenesis, migration, invasion, adhesion, and metastasis. These receptors are expressed by several tumor cell types and are implicated in tumor growth and progression. Gilteritinib has been shown to inhibit the growth of cultured human leukemic cells in vitro and xenograft models of human solid tumors in vivo." - Anonymous Online Contributor
"Survival rate depends on many factors however, it seems that age, gender, and type of leukemia are the strongest predictors of long-term prognosis in patients with acute myelogenous leukemia. Patients with less than 50 years of age have a better prognosis compared to patients over 60 years of age. For acute lymphoblastic leukemia, age was also found to be a predictor of prognosis. Marrow transplantation improves the prognosis tremendously for those with acute leukemia. In 1971, the US National Comprehensive Cancer Network (NCCN) established five-year survival rates for AML, ALL, CLL, and DLBC to be approximately 90%, 80%, 65%, and 40% respectively." - Anonymous Online Contributor
"The most common cause of childhood leukemia is exposure to ionizing radiation that occurred during pregnancy, birth, infancy, or adulthood. Certain chemicals also increase the risk, including benzene, cadmium, tobacco smoke and lead. Exposure to certain types of infectious agents such as "Toxoplasma gondii" and human herpesvirus 8 (HHV-8) may also play a role in pediatric leukemia. In children, hereditary syndromes such as Down syndrome, Fanconi anemia, and Wiskott–Aldrich syndrome increase the likelihood of developing childhood leukemia." - Anonymous Online Contributor
"The majority of patients had been treated previously with conventional chemotherapeutic regimens. Patients with refractory disease were more likely to receive second-line therapy. The survival rate was poor, probably due to advanced age or comorbidities." - Anonymous Online Contributor
"Findings from a recent study demonstrate significant family aggregation of leukemia risk factors, suggesting that genetic predisposition to leukemia may be inherited genetically in some cases." - Anonymous Online Contributor
"There is huge interest in the new developments in the field of cancer biology, especially concerning the genes in which a mutation is present in a specific part of the genome. These mutations may affect gene expression and thus lead to the development of cancer. Furthermore, they might cause problems during the normal development of an organism. The latter phenomenon is called oncogene, and accounts for many hereditary forms of cancer. Some of the most studied oncogenes include those that code for the products of the MYC (myelocytomatosis related cellular transformation 1), RAS (gene) and BCL2 (B-cell lymphoma 2) protooncogenes." - Anonymous Online Contributor
"Heclininab has shown promising activity in patients with advanced B-cell malignancies who have received at least two prior lines of therapy. Patients with objective responses had an average progression-free survival of 10.7 months (95% CI, 7.2-14.1) and an overall response rate of 39%. Patients also demonstrated significant reductions in serum lactate dehydrogenase (LDH) levels compared with baseline values, indicating that heclinab may exert its antitumor effects through antiangiogenic mechanisms. However, clinical studies are necessary to confirm these findings. Furthermore, patients with LM/NOS (lymphoma, myeloma, or ALD) should be excluded from this trial." - Anonymous Online Contributor
"Gilteritinib is commonly used in combination with other agents or as monotherapy. Some of its most common combinations are with chemotherapy (e.g., doxorubicin, etoposide), immunotherapy (e.g., pembrolizumab), or targeted therapies (e.g., imatinib, erlotinib, sorafenib). Combinations with immunotherapy and/or targeted therapies are often referred to as "combined immune-targeted therapy" (CIT) and include gilteritinib with pembrolizumab or atezolizumab.Gilteritinib has low toxicity and few side effects compared with many newer drugs." - Anonymous Online Contributor
"Given the current knowledge of the biology of leukemia, it appears that cure cannot be achieved. This does not mean that patients will die - rather, their chances of survival may be greatly improved by treatment. Despite the overwhelming progress made in gene therapy, the biological basis for chemotherapy remains elusive. However, the problems associated with gene therapy are now being tackled by a new generation of drugs which act directly on the cancerous gene itself and hence have fewer adverse effects. There is also evidence that targeting tumor initiation pathways might provide additional benefits. Current advances in treating CML are directed towards overcoming drug resistance and prolonging survival. In addition, long-term studies of survivors are being conducted at many different institutions around the world." - Anonymous Online Contributor
"Gilteritinib is an oral inhibitor of Src family kinases, including FLT3, PDGFRα, EGFR, and c-Src. Gilteritinib was developed as anticancer agent by GlaxoSmithKline (GSK) based on its role as an inhibitor of the Src tyrosine kinase activity in certain tumor cell lines. In vitro assays demonstrated that gilteritinib has anti-proliferative activity against both normal and malignant cells, and inhibits growth of head and neck squamous carcinoma xenografts grown in athymic mice." - Anonymous Online Contributor
"At present, there is no reliable method for predicting the early spread of leukemias. However, from our experience, we think that a low percentage of patients have advanced stages by the time of diagnosis. For example, our patient population has a median age of 48 years; therefore, he or she may be diagnosed with an indolent disease when the tumor is small enough to remain localized and unnoticed in the bone marrow. And even if the disease did progress to more advanced stages, it progressed slowly because of the low percentage of the patient population who had advanced stages of the disease. We think that this phenomenon might apply to other types of cancers." - Anonymous Online Contributor