This trial is evaluating whether BLINCYTO (Blinatumomab) will improve 2 primary outcomes, 2 secondary outcomes, and 5 other outcomes in patients with Leukemia. Measurement will happen over the course of From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
This trial requires 30 total participants across 3 different treatment groups
This trial involves 3 different treatments. BLINCYTO (Blinatumomab) is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
This preliminary study provides preliminary evidence that blincyto in combination with other chemotherapeutic regimens is safe in this population. This was a Phase 2b trial and no long-term data are available to support conclusions of safety or efficacy\n
In the US, the overall risk of developing leukemia is 6-times higher in the United States than in Western Europe. The incidence rate of ALL increases with age to a peak in the fifth decade but afterwards it declines. CLL has a lower lifetime risk compared to ALL by approximately 30%; however, this has a lower incidence rate and more pronounced age and sex dependency.
Leukemia is defined as any type of blood cancer in which cells fail to undergo cell division properly and is the result of the development of acquired genetic abnormalities. These genetic abnormalities arise from errors in DNA repair and programmed cell death. There are three types of leukemia: myeloid, lymphoid, and acute. These are categorized based on the type of blood cell affected, cell origin, cause, and the ability of the disease to spread to other areas of the body. The word lymphangioma refers to a tumor composed of lymph tissue that has grown outside the confines of its lymph channels and filled the lymph system with nodules.
There are many different types of leukemia and causes that can be linked to the type or location of cancer. Most cancers have a strong genetic basis, but all types of leukemia can have more than one factor that can worsen the chances of developing the disease.\n
The prognosis of acute leukemia does depend on the level of immunosuppression at diagnosis, its duration, and treatment with other types of chemotherapy and the relapse schedule. These factors strongly influence the rate of remission in patients with acute leukemia. However, these effects are too weak to justify any talk about curing leukemia.
The American Cancer Society reports a 20 percent decrease in new cases of leukemia and myeloid leukemia over the past 25 years. This decline in the disease incidence is attributed to increased use of chemoradiation. The number of new cases of lymphoid leukemia or multiple myeloma has remained stable since 1995. Rates of AML have more than doubled since 1987 and now equal rates of ALL since 1987 have increased fourfold.
Signs of leukemia may be experienced by many people without leukemia. Individuals may be unaware of symptoms for a long time. Certain symptoms, such as fever and night sweats, are more suggestive of leukemia than others. Symptoms of leukemia are often present (or at least felt) in these people. The most common signs of leukemia are headaches and loss of appetite. Signs of leukemia can be debilitating. Many people with leukemia, especially those who are very young or very old, may feel their symptoms are not as severe.\n
For patients with ALL the relative 5 year survival rate is 92.2%, 95.7% and 94.2% for 2-stage 2, 2-stage 3 trials respectively, with relapse only affecting 15.9% of patients, regardless of trial stage. For most ALL children, 5 year survival remains near 90%, irrespective of treatment. In contrast, for CLL the relative 5 year survival rate is 73%, regardless of treatment. For CML, survival rates between trials and treatment levels are less clear, and the relative survivals remain fairly constant. Nevertheless, overall survival of CML patients is around 72% 5 year survival, and CEL patients have around 68%.
The majority of people diagnosed with ALL before 20-25 years of age, this is probably because leukemia is usually the first presentation of malignancy in the youth. This statistic should be used in designing and evaluating diagnostic screening programs in the pediatric population. When leukemia is diagnosed in the adult population, age is rarely used as a diagnostic criterion for this disease.
Blincyto provided a small but nonsignificant improvement over a placebo in improving disease-free survival and achieving remission in patients with previously treated chronic lymphocytic leukemia.
With our present knowledge it is possible to predict a good prognosis in a sizeable proportion of ALL case; however, it has to be emphasized that these good prognoses are often not achieved by ALL patients unless they enter a phase of complete treatment. It is necessary to guarantee that ALL patients are going to get adequate treatment and that the treatment is free of toxicity.