This trial is evaluating whether venetoclax will improve 2 primary outcomes and 11 secondary outcomes in patients with Leukemia, Myeloid, Acute. Measurement will happen over the course of 30 days & 60 days from start of study treatment.
This trial requires 55 total participants across 2 different treatment groups
This trial involves 2 different treatments. Venetoclax 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 & 2 and have already been tested with other people.
A person presenting with the constellation of signs and symptoms of acute leukemias and/meningococcal sepsis may have acute lymphoblastic, myeloblastic or myelocytic leukemia, myeloproliferative or non-myeloblastic, acute. Treatment of those with myeloblastic leukemia involves a complete blood count, bone marrow study, and blood film. Acute leukemia, however, is usually distinguished from acute monocytic leukemia by the presence of a granulocytic proliferation on the blood film.
Recent findings point to the hypothesis that acute myeloid leukemia results from chronic myelogenous leukemia. The mechanism is in dispute due to the fact that acute leukemia often presents with a range of symptomatology and has different prognoses.
Leukemia, myeloid, acute is a blood or bone marrow marrow disorder in which there is an increase in the number of white blood cells. This typically occurs by one of the following three main mechanisms: (i) clonal multiplication of normal cells; (ii) the development of abnormally circulating leukemic cells; and (iii) the transformation of normal blood cell precursors into leukemic cells that circulate in the blood. Patients with leukemia, myeloid, acute should have full blood cell count, complete blood test, and bone marrow study done.
A total of 8.2/100,000 (0.008%) got leukemia/myeloid/acute a year. The risk of getting leukemia/myeloid/acute is higher in women (4.0/100,000, < 0.04%) than in men (2.3/100,000, < 0.02). Only 23% of patients had used a blood-forming agent in the last 6 months.
Data from a recent study the most common treatment for AML and ALL was allogeneic stem cell transplantation (HSCT). However, more than 85% of the patients did not receive HSCT, instead being treated aggressively by intensive chemotherapy with autologous stem cell support and donor allogeneic stem cell transplantation. In addition, nearly half of the patients did not receive HSCT as their only treatment of last resort. This should serve as a reminder to clinicians that the use of allogeneic stem cell transplantation is limited.
Overall, leukemia, myeloid, acute survivors have modest risks of subsequent acute-complications, and survival after first leukemia is similar to survival in the general population. Patients with leukemia, myeloid, acute have a modest absolute overall risk of cancer, but there exists a higher relative risk of subsequent acute-complications.
According to the Global Burden of Disease (GLOBBEM), Myeloid, acute leukaemia is the most prevalent type of leukemia in the UK. Also, when combined with other global estimates, the UK incidence of leukaemia, myeloid, acute is 28.1 per 100,000 people. According to [World Cancer Report (2017)], European incidence of leukemia, myeloid, acute is 2.4 per 100,000 people.
At diagnosis the prognosis is poor in acute myeloid leukemia patients with high WBC count and high M-CSF levels. In such cases clinical trials should not be considered.
Azacitidine is safe with a relatively high remission rate and generally well tolerated with some common adverse effects. Gastrointestinal adverse events such as diarrhea and vomiting affect more than 4% of patients.
The QoL profile for pediatric AML patients receiving Azacitidine for standard treatment was comparable to that reported in other patients with leukemia who do not receive Azacitidine. Azacitidine was well tolerated.
Patients are unlikely to outlive their leukemia, regardless of treatment, which makes a cure more likely a goal than survival. Most patients with leukemia will eventually have to receive treatment that is not curative. The treatment will eliminate the disease and prevent it from recurring in the future. Only 5% of patients survive 1 year. A cure is not a goal in treatment of this disease.
The use of azacitidine was commonly in combination with a number of treatment modalities. Results from a recent clinical trial show the importance of comprehensive understanding of the clinical implications of azacitidine use in the treatment of leukemia.