AMG 553 for Leukemia
Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML
See full descriptionAbout the trial for Leukemia
Treatment Groups
This trial involves 2 different treatments. AMG 553 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
Eligibility
This trial is for patients born any sex of any age. You must have received 1 prior treatment for Leukemia or one of the other 3 conditions listed above. There are 3 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether AMG 553 will improve 3 primary outcomes and 10 secondary outcomes in patients with Leukemia. Measurement will happen over the course of 3 months.
Patient Q & A Section
What are common treatments for leukemia?
The most common treatment for leukemia is chemotherapy. Patients who choose this treatment are often advised that the chances of cure are much lower with chemotherapy, with a five-year survival rate of 15-30%.
Can leukemia be cured?
For leukemia patients, who are eligible for stem cell transplantation, the probability of cure is relatively high. For the leukemia patients who have persistent, progressive chemotherapy resistance, the likelihood of cure is lower. Further prospective studies are needed to clarify the effect in nonhematological cancer cases.
What are the signs of leukemia?
Many of the signs of leukemia are nonspecific and are present in other serious illnesses. In some instances, symptoms like fever, night sweats, and anemia are the only signs of leukemia. Other signs of leukemia can include pale or puffy complexion, loss of appetite, and a yellow tint to the whites of the eye (jaundice). The symptoms may not appear for a long time or new symptoms may appear when the cancer is progressing. Often the signs and symptoms of leukemia do not appear until the cancer has progressed to a more serious stage.
What is leukemia?
The human body naturally has a variety of defenses against the invading microorganisms that may spread to become cancer. The body's most familiar defense is the immune system. This system is composed of a series of organ systems that work together to destroy an infection. The immune system destroys or eliminates an invader with the use of a unique method: “targeted killing”. Targets of immune destruction are called antigens. Antigenic targets are cells, organs, or tissues that express particular antigens and are generally abnormal, new (i.e. foreign and unique), or have no function in the body.
How many people get leukemia a year in the United States?
Cancer survivors are a diverse group, with varying levels of survivorship, cancer and survivors' needs. Strategies are needed to support those who make the transitions and improve survivorship.
What causes leukemia?
Leukemia is caused by a number of factors in both genetic and environmental causes. In the United States, more than half of all leukemia cases are diagnosed as a result of immunodeficiency and a low birth weight. Infections such as human herpesvirus 8, rubella, and cytomegalovirus are also possible causes. Exposure to tobacco or asbestos is also a known risk for leukemia development. Leukemia is more common and is usually less aggressive in the tropics than in the temperate climates. It is also less common in males.
What is amg 553?
This AMG 553 compound has been designed for the purpose of improving leukemia cell binding to the bone marrow in order to facilitate AMG 553 mediated bone marrow ablation. The presence of the phenylglyoxal moiety in AMG 553 enhances its osteomimetic activity. These data strongly support further development of AMG 553, which is currently being investigated in two early-phase clinical trials, one in patients with relapsed/refractory CLL and one in patients with AML.
What are the latest developments in amg 553 for therapeutic use?
The development of amg 553 was an important milestone as researchers now have the most potent and well-tolerated, long-acting CML therapy in its history. The drug has been well tolerated in a phase 3 study including patients with relapsed or prior therapy CML and shows evidence of efficacy in phase II and a phase II/III clinical development. Currently amg 553 is being developed for use in clinical trials. In July 2009, amg 553 was granted breakthrough therapy status by the FDA, a first for a targeted therapy used to treat CML. Amg 553 is being developed for the treatment of CML; a first for a targeted therapy used to treat CML.
Has amg 553 proven to be more effective than a placebo?
The study was not powered to be conclusive, but there were no significant differences on secondary analyses, including safety. Results from a recent paper of this research will guide the future design of further trials of AMB 553.
What is the latest research for leukemia?
There are many studies going on for leukemia. There is no doubt that we are learning much more about it than we ever knew. There is still great potential research for this disease.
Who should consider clinical trials for leukemia?
Clinical trials should be offered to all patients for the benefit of achieving the maximum amount of treatment benefits. The only criteria for patients to be eligible for clinical trials is to be very young or very old. However, most patients with this disease tend to be elderly or middle aged. A study has shown that they will receive more benefits if they are selected by physicians or hematologists. Therefore, we propose that trials should be encouraged for all patients of ALL.
Does leukemia run in families?
Leukemia runs in families and the clinical course of disease in the kindreds of the family is more aggressive and unfavorable. Results from a recent paper indicate germ-line mutations predispose the afflicted family members to the development of chronic phase chronic myeloid leukemia.