This trial is evaluating whether ME-401 will improve 7 primary outcomes and 10 secondary outcomes in patients with Leukemia, Lymphocytic, Chronic, B-Cell. Measurement will happen over the course of within the first 56 days.
This trial requires 177 total participants across 3 different treatment groups
This trial involves 3 different treatments. ME-401 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 1 and are in the first stage of evaluation with people.
The cause of chronic, aggressive leukemias has not been clearly defined, though genetic defects in the cells of the bone marrow might be involved. Lymphocytic leukemia and acute leukemias are both chemotherapeutic diseases that are treated by chemotherapy. Lymphoma and leukemium are diseases characterized by a lymphocytic infiltrate in the tissues.
Around 9% of all cases of leukemia, lymphocytic, chronic, b-cell are diagnosed each year in the United States. As a whole, leukemia, lymphocytic, chronic, b-cell affects almost 300,000 persons a year in the United States. Most cases of leukemia, lymphocytic, chronic, b-cell (about 60% of all cases) are diagnosed in male subjects.
While some types of leukemia (lymphoid) may respond well to immunosuppressive therapy (such as cyclophosphamide/hydrocortisone/sulfasalazine), the treatment for most leukemia is chemotherapy (such as cytarabine, methotrexate, etoposide, or fludarabine). Also, while some lymphoid leukemias may respond in the initial weeks or months of chemotherapy, most relapse very quickly. A small proportion of lymphoid leukemias may respond to chemotherapy such as methotrexate, mercaptopurine, fludarabine, or amsacrine, in particular the B-cell kinds.
Recent findings is the first, and perhaps only, to employ and compare two different techniques that have been shown by independent investigators to be effective and safe in achieving remission in chronic B-cell leukemias.
A person most commonly becomes ill because of an infection or other disease. About 20 percent of deaths are tied to leukemia and lymphoma. There are specific types of leukemia and lymphoma. In most industrialized countries, cancer as a cause of death is declining because of advances in treatments and in the quality of life. The causes of cancer, lymphoma, and leukemia have not been determined for most of the diseases, so the causes of most forms of cancer, lymphoma, and leukemia are unknown.
When leukemia is diagnosed, the prognosis is poor. The most common symptoms include fatigue, weight loss and swelling hands and feet, swollen adenopathy and malaise. The first symptom to occur is fatigue. The diagnosis can be confirmed by blood tests that indicate the presence of certain blood cell types. Some of the less common symptoms relate to the leukemia type. They include rash, itching or dry skin, and skin lesions such as pimples or other lesions.
Although the overall 5-year survival rate for leukemia, lymphocytic, chronic, and B-cell is 80-85%; the most recent data suggest that survival rates are steadily improving. The most common causes of death in leukemia are relapse, or the growth of cancer cells which have developed resistance or become defective. The most common cause of death in lymphocytic chronic cancers is infection.
There has been considerable progress made over the past 20 years in the development of new forms of therapy for leukemia in adults. However, in the treatment of chronic lymphocytic leukemia, the majority of patients with relapsed disease are managed with a single oral drug, pentostatin, in combination with interferon. The use of a combination of cytotoxic agents for myelodiplastic syndromes (treatments for which more than one drug is used) is being investigated. In particular, a study of low-dose vincristine therapy is in progress. In the management of acute myeloid leukemia, therapies used in clinical trials have been developed that are based on the underlying nature of the disease.
Listed herein is the order in which leukemia, lymphocytic, chronic, b-cell appears on the bone marrow smear as a result of blood transfusion, aspiration, or aspiration and bone marrow biopsy. This does not correlate with which leukemia will be seen most often in a particular location on the bone marrow or the age of patients. As such, it is not an accurate method of predicting which subtypes of leukemia may appear preferentially in particular areas of the body.
Patients with lymphocytic, chronic, B-cell leukemias are at a higher risk of death. Patients with acute lymphocytic leukemia have a higher survival, especially if the disease is in remission (69%). Patients with chronic lymphocytic leukemia are at a higher risk of relapse, even if the disease is in remission (38% in one study). Patients with chronic myeloid leukemia had a higher rate of relapse (22% over several years of treatment).
Results from a recent paper demonstrates that in families with B-CLL at least two cases must be present in order to demonstrate an increased frequency of lymphadenopathies, lung, breast and other cancers and skin and/or gut malignancies. These families may experience delays in diagnosing familial B-CLL.
Results from a recent clinical trial from these studies demonstrate that therapy with me-401 at 2 μg was more effective than that therapy with the placebo. In addition, there were no important differences between the treatments of me-401 and that of the non-me-401 groups. Further studies are required to clarify the precise mechanisms by which me-401 exerts its therapeutic effects.