Cobimetinib for Leukemia, Myelomonocytic, Chronic
Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations
See full descriptionAbout the trial for Leukemia, Myelomonocytic, Chronic
Treatment Groups
This trial involves 2 different treatments. Cobimetinib 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 2 and have already been tested with other people.
About The Treatment
Side Effect Profile for Pembrolizumab
Eligibility
This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Leukemia, Myelomonocytic, Chronic or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Cobimetinib will improve 1 primary outcome and 4 secondary outcomes in patients with Leukemia, Myelomonocytic, Chronic. Measurement will happen over the course of Until decision to end treatment or up to 12 months of treatment, whichever came first.
Patient Q & A Section
What does cobimetinib usually treat?
Cobimetinib is an effective and well-tolerated treatment for patients with LAM/MDS or ES-AM. The most common ALT abnormalities were the same as reported in previously reported trials, although ALT elevations > 3.0 times the cutoff are frequently seen in patients with gastrointestinal involvement. The combination of ALT elevations and hepatomegaly seems especially noteworthy, as they can present with severe hepatotoxicity.
What is leukemia, myelomonocytic, chronic?
Chronic myelomonocytic leukemia is a subtype of leukemia. A person with chronic myelomonocytic leukemia has a significantly increased risk of developing acute myeloid leukemia and a subunit transformation of leukemia in a first remission. The chronic phase of chronic myelomonocytic leukemia is characterized by low blast counts in the peripheral blood and splenomegaly. Acute myeloid leukemia and chronic myelomonocytic leukemia can be differentiated on the basis of their bone marrow smear appearance. Myelomonocytic leukemias can be classified according to their underlying cause, the morphology of the neoplastic cells, and according to organ involvement.
What are the signs of leukemia, myelomonocytic, chronic?
Patients are at an increased risk of myeloma and chronic phase chronic myeloid leukemia (CML) if they have leukaemia, myelomonocytic, chronic with a chronic phase CML gene mutation. The prognosis for AML, chronic phase CML, or chronic phase CML is poorer if they have CML with an ATM/ATF8-related CML mutation. These data help in the risk assessment of both these myeloproliferative forms of chronic myeloid leukaemia and will aid in deciding a risk stratification for therapy.
What causes leukemia, myelomonocytic, chronic?
The main causes of chronic disease are not infections or genetic abnormalities, and are not different in patients with leukemia versus those with myelomonocytic chronic disease. The same mechanisms that underlie leukemia, myelomonocytic chronic ischemic disease do not cause chronic disease in other areas of the cardiovascular system, and are likely to be involved in pathophysiology of all the diseases.
Can leukemia, myelomonocytic, chronic be cured?
This case confirms that there are still doubts about [if a cure is realistic and possible]. Still, if one wants to cure a leukemic disease, it is important to think about more advanced cases that have less favorable prognoses.
What are common treatments for leukemia, myelomonocytic, chronic?
There are two treatments: first line (intensified chemotherapy) and (intensified chemotherapy + stem cell transplant). First line is used for chronic myeloid leukemia in all age groups. Second line treatment may be used for young patients with acute promyelocytic leukemia, myelomonocytic leukemia in adulthood, or chronic myelomonocytic leukemia of adults with good performance status, or children with AML with good performance status and normal karyotype. The choice of treatment according to the disease and overall condition of the patient in any subgroup of patients is debated by specialists.
How many people get leukemia, myelomonocytic, chronic a year in the United States?
About 2,200 people per year are diagnosed in the United States with leukemia, myelomonocytic, chronic. This is a relatively low rate compared to other countries, however an increase of this number is expected when analyzing data from different institutions. Because of the lower cost of maintenance treatment in the USA, this disease could be one of the preferred ones for the budget makers.
What is the average age someone gets leukemia, myelomonocytic, chronic?
In this cohort of patients with leukemia, the average age of diagnosis was 61.8 years with a median of 5.8 years. Younger patients presented with acute myeloid leukemia (AML) at a mean age of 37.1 years, and older patients presented with lymphoid malignancies at a mean age of 60.7 years. Younger age at relapse was associated with more aggressive disease with a poorer prognosis.
What are the common side effects of cobimetinib?
This pooled analysis of clinical trial data from 1110 patients with EGFR mutant (del 19/21) solid tumors is the largest one to date reporting the overall side effects of this therapy. Common (>10% incidence) and dose-limiting toxicities were diarrhea (30%), fatigue (21%), nausea/vomiting (19%), decreased appetite (17%), decreased haemoglobin (11%), neutropenia (11%), fatigue (10%), thromboembolisms (<10%) and skin rash/skin irritation (10%).
What is the primary cause of leukemia, myelomonocytic, chronic?
Chronic myelogenous leukemia, not acute lymphoid leukemia, may have an unknown genetic cause. Other causes of chronic myelomonocytic leukemia are rare. The primary cause of chronic myelomonocytic leukemia, a chronic leukemoid reaction, is unknown.
How does cobimetinib work?
Cobimetinib inhibits oncohematological and autoimmune neoplasms in vivo, by blocking STAT3-mediated STAT5 phosphorylation. It may represent a beneficial new option to treat B cell malignancies, including non-Hodgkin's lymphomas and multiple myelomas, the latter notoriously refractory to treatment regardless of the first line treatment used.
Who should consider clinical trials for leukemia, myelomonocytic, chronic?
Patients with acute myeloid leukemia or chronic myeloid leukemia most likely will benefit from clinical trials. However, there are no good trials specifically for acute lymphoblastic leukemia, and most clinical trials are either of poor quality or do not meet current standards for testing clinical outcomes. For all clinical trials for leukemia, it is important to examine trial results in the largest, longest-lasting trials that have been completed.