This trial is evaluating whether Decitabine and Cedazuridine will improve 1 primary outcome, 5 secondary outcomes, and 2 other outcomes in patients with Acute Myeloid Leukemia (AML). Measurement will happen over the course of From complete remission or complete remission with incomplete count recovery until date of first objective documentation of relapse or death, assessed up to 5 years.
This trial requires 125 total participants across 5 different treatment groups
This trial involves 5 different treatments. Decitabine And Cedazuridine is the primary treatment being studied. Participants will be divided into 5 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.
"This section will summarize recent advances in the understanding of leukemogenesis and its therapy. It has long been suspected that the uncontrolled proliferation of white blood cells is the pathologic basis of leukemia. Today, it is well known that leukemia develops from hematopoietic stem cells (HSC), which give rise to all blood cell types through differentiation. However, the mechanism of progression from HSC to LSC was not fully understood until recently." - Anonymous Online Contributor
"Decitabine and cedazuridine can be administered safely as a single agent during all phases of chemotherapy for high-risk MDS. Both agents have been shown to increase overall response rates when used in combination with other chemotherapy regimens, but only decitabine has been associated with improved progression-free survival." - Anonymous Online Contributor
"Decitabine was superior to the previously used agent, dideoxycytidine, for achieving remission of AML. Higher rates of remission were observed in patients treated with decitabine (55%) versus those treated with dideoxycytidine (40%).decitabine is now approved for usage in the United States. However, there is no evidence that it improves survival. Cedazuridine has not been approved for use in the United States. In Europe, however, it is approved for use in combination with fludarabine and cyclophosphamide for treating newly diagnosed refractory AML. ClinicalTrials.gov Identifier: NCT01616861." - Anonymous Online Contributor
"Clinical trials represent an important option for patients with newly diagnosed AML. However, there is no clear evidence that participation in a clinical trial alters survival outcomes." - Anonymous Online Contributor
"Yes, it is possible to cure a person with acute leukemia, myeloid, or lymphoma by treatment with chemotherapy. This cure is most likely if all the necessary steps are taken before the disease gets bad enough to start treatment. The more advanced the disease is at diagnosis, the less likely it is that a cure will happen. Doctors use multiple treatments to fight leukemia, though the exact treatment plan depends upon the type of leukemia and the stage of the disease. After treatment, all three types of leukemia can be cured. If the leukemia has not spread beyond the bone marrow and stays there, then the chances of being cured are stronger. The chance of being cured increases as the number of treatments a person has received decreases over time." - Anonymous Online Contributor
"Decitabine and cedazuridine are both effective, safe, and well tolerated for the treatment of patients with advanced malignancies. Although there was no difference between the two drugs in terms of the major adverse events included In a recent study, we observed a higher incidence of nausea and neutropenia among patients given decitabine than those given cedazuridine." - Anonymous Online Contributor
"In addition to the results from our initial study, we found the addition of decitabine plus cedazuridine to standard intensive chemotherapy provides no benefit compared with standard-intensity chemotherapy with both agents. Considering the number of patients needed to detect a meaningful difference in survival, our study suggests that this strategy is not cost-effective." - Anonymous Online Contributor
"Results from a recent clinical trial supports the hypothesis that AML runs in families and that other types of ALL do not seem to run in families." - Anonymous Online Contributor
"Myeloid, acute leukemia is caused by uncontrolled cell growth in the bone marrow. There are many genetic mutations that contribute to leukemia. However, there is one specific gene mutation (TET2) that makes up about 30% of all cases of leukemia. TET2 is an enzyme that helps to maintain normal blood cell numbers and functions correctly. When TET2 doesn't work properly, the body's defenses against cancer go wrong. This is why it is important to understand what works in different patients so doctors can prescribe the best treatment. [Anderson et al.](https://www.ncbi.nlm.nih.gov/books/NBK06726/check_lists/hemlock_trivellona." - Anonymous Online Contributor
"The majority of acute leukemia cases were caused by a genetic defect in one or more of the components of the DNA repair pathway. This is consistent with the notion that cancer is due to a gradual accumulation of mutations in DNA repair genes. However, there was limited evidence for other mechanisms, such as environmental factors influencing the expression of DNA repair genes or epigenetic changes leading to decreased DNA repair." - Anonymous Online Contributor
"Acute leukemias and myeloproliferative disorders comprise a heterogeneous group of diseases. This article focuses on acute myeloid leukemia (AML). AML is one of the most common cancers diagnosed in young adults, making up approximately 20% of all cases in adults age 18-35 years. The incidence rate of AML has increased over the past two decades. As of 2008, it was estimated that 15-20% of newly diagnosed patients had AML as their initial diagnosis, while 25% of patients with AML will die within 5 years from diagnosis. Much of the information presented here is generalizable to other forms of AML." - Anonymous Online Contributor