This trial is evaluating whether Azacitidine will improve 1 primary outcome and 19 secondary outcomes in patients with Leukemia, Myeloid, Acute. Measurement will happen over the course of Up to 8 weeks.
This trial requires 172 total participants across 2 different treatment groups
This trial involves 2 different treatments. Azacitidine 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 2 and have already been tested with other people.
Symptoms vary between people with leukemia and those with myeloid acute leukemia. For people with acute leukemia the most common symptoms are fever, chills, headache, and malaise. Fatigue, easy bruising or bleeding, feeling nauseated or tired and shortness of breath are also common.\n
About 3500 people die from myeloid leukemia in the US each year. About 20% of myeloid leukemia deaths occur in children under 15, 20-30% of all leukemia deaths occur in people 35-44 years of age, and approximately 70% of all leukemia deaths occur in men. About 5000 people die from lymphoid leukemia every year. About 20% of lymphoid leukemia deaths occur in children under 15, 20-30% of lymphoid leukemia deaths occur in people 35-44 years of age, and approximately 80% of lymphoid leukemia deaths occur in men. About 2000 people die from acute leukemia in the US each year. Approximately 75% of acute leukemia deaths involve acute promyelocytic leukemia.
Leukemia, myeloid, acute is the second most frequent cause of cancer-related deaths in the United States, following lung cancer. The annual incidence of leukemia-myeloid-acute is about 40 new cases per 100,000 people per year. About 40% of leukemia-myeloid-acute people also have myelodysplastic syndrome (MDS) at diagnosis, so the incidence of leukemia-myeloid-acute will increase due to the increased incidence of MDS. About 80% of people with leukemia-myeloid-acute are in good clinical grade at presentation, so the treatment of leukemia-myeloid-acute could be improved.
The common treatments for leukemia, myeloid, acute are diverse and include chemotherapy, allerbutics, biomedicines, antimetabolites, and leukotriene modifiers. Leukotriene modifiers appear to represent a valid treatment option for patients with acute myeloid leukemias or myelodysplastic syndromes who cannot tolerate standard chemotherapies.
Patients with AML-M are rare and have dismal prognoses. AML-M is currently not curable for most patients. Patients with AML-M without an M1-M3 or a bulky M3 have good to excellent survival, while patients with M1 or bulky M3 have fatal disease. AML-M can be treated and patients can benefit from treatment. For the M1-M3 patients, more effective treatments are warranted. Patients with bulky M3 disease may benefit from newer agent- combinations.
Multiple myeloma can be caused by a genetic predisposition as well as exposure to environmental agents. Many types of leukemias originate in the bone marrow. The exact cause is unknown. The exact cause of acute myelogenous leukemia is unknown, but it is known to be associated with viruses and certain environmental agents.
Azacitidine improves QoL in patients with AML and myeloid, acute leukemias. The improvements in QoL are not only related to cytoreduction and marrow aplasia reduction but also to symptomatic relief, fatigue/mood enhancement (at 12 weeks), and better treatment tolerance (tuberous sclerosis complex, or TSC). Azacitidine also seems to have a modest role in treatment-resistant myeloid, acute leukemias.
Azacitidine was well tolerated. Commonly reported general tolerability adverse effects were nausea (24%; 5/17 patients), fatigue (17%; 4/17 patients), and loss of appetite (17%; 4/17 patients).
Patients receiving azacitidine in combination with other treatments generally experience more disease progression at time of report than those receiving azacitidine alone. Because many patients experience a delay in referral by their oncologists after initiating treatment, the inclusion of azacitidine in the treatment of pediatric patients undergoing induction therapy with chemotherapy has a number of important implications for clinical trials of pediatric hematologic malignant neoplasms, especially those involving chronic myeloid leukemia.
This is the largest family study of acute lymphocytic leukemia susceptibility among Caucasians to date. Findings from a recent study show that this disorder is likely to be due to multiple genes and environmental exposures in an additive manner.
Results from a recent clinical trial suggest that survival varies for leukemia, myeloid, acute survivors. The survival rate increases consistently with age at diagnosis for leukemia and myeloid, acute. In leukemia patients, survivors seem to have different survival rates depending on the time of diagnosis. Patients who were diagnosed>5 years ago had higher survival rates than survivors who were diagnosed<5 years ago. We do not know if this was a real effect of earlier treatment or treatment-related variables.
Although clinical trials suggest that the response to azacitidine in MDS is less than 10% in patients with CMML, our results indicate that azacitidine may be an important medication in CMML treatment. More clinical trials are warranted.