Frequently Asked Questions

A clinical trial is a research study that examines how well a potential therapy works in humans.

Qualified doctors, nurses and other medical professionals conduct the study. Clinical trials are performed according to government regulations, which help protect the safety and rights of participants.

New medications can only be developed through the process of clinical trials.

Many relapsed or refractory AML patients today are not eligible for potentially curative bone marrow transplant because of their health status or they have active disease and are unable to get into remission with chemotherapy.

The SIERRA trial does not require a patient to be in remission to potentially get a bone marrow transplant and is investigating the use of ¹³¹I apamistamab (Iomab-B) in patients age 55 and older with active, relapsed or refractory Acute Myeloid Leukemia (AML).

The purpose of this study is to determine whether ¹³¹I apamistamab (Iomab-B) will help make the stem cell transplant procedure safer, and whether this is a better treatment approach compared to current treatment options.

SIERRA may be an option for you.

This clinical trial has certain criteria that a person with relapsed or refractory AML has to meet to determine if they can participate. After you have discussed the trial with your doctor, specific tests will be done to see if you qualify for this study. Please click here to download/print details of the SIERRA Trial to review with your doctor.

Actinium Pharmaceuticals is sponsoring this multi-center clinical trial.

The total number of AML patients enrolled in this clinical trial will be approximately 150. Your doctor can provide additional details about the SIERRA Trial. Please click here to download/print details of the SIERRA Trial to review with your doctor.

Visit our contact a study location page to see the list of participating sites.

The chances of developing any type of cancer is a combination of both genetic and environmental factors.  Typically, environmental factors are cited as the most important factor in a person developing AML.  Siblings and even identical twins of an AML patient only have a slightly increased risk of developing AML in comparison to the general population.⁷  Thus, inherited mutations are not a common cause of AML.

While familial AML is a very rare type of inherited leukemia, other genetic factors like Down’s Syndrome, congenital neutropenia, and Fanconi’s anemia are all associated with an increased likelihood of developing AML.

The DNA changes that are associated with AML typically occur over the course of a person’s lifetime, as opposed to being inherited from birth.  These DNA abnormalities are typically triggered by environmental factors such as radiation or other carcinogens.  Some people who develop AML have no known risk factors.  

The genes associated with cancers, including AML, control how our cells function, in particular the way our cells grow, divide, or die.  Changes in certain genes such as FLT3, c-KIT, and RAS are common in AML cells.  These changes affect the way our bone marrow cells mature and form new blood and bone marrow cells.  

Even though AML is the second most common type of leukemia diagnosed in adults and children, the National Cancer Institute estimates that .5% of American men and women will receive a diagnosis of AML at some point in their life. 

Most cases of AML occur in adults. In fact, AML makes up 31% of all adult leukemia cases. Although AML can be diagnosed at any age, it is uncommon before age 45.³

The life expectancy of people with acute myeloid leukemia varies greatly from one person to another. The survival rate depends on the subtype of AML the individual has, the stage of the disease, the patient’s age at onset and the patient’s overall health condition at the time of diagnosis.

Patients diagnosed with AML are generally in their 60s or 70s, and more than half of the AML patient population is over 65.¹  Recent studies have shown that most AML patients (up to 80 years of age) benefit from intensive chemotherapy.²  Patients older than 80 typically have a poor long term prognosis when diagnosed with AML.  This is in part due to comorbidities that may be present in this age group.  

The 5-year relative survival rate (RSR) for people with acute myeloid leukemia (AML) is 30.5%. This statistic, however, includes all people with AML, and survival rates decrease significantly as age progresses. 

Two out of three people⁴ who receive chemotherapy for AML experience disease remission.  For those under the age of 40, the two year survival rate is 47.7% vs 23.6% for those aged 41-60, and 11.7% for those over the age of 61.⁵

There are many treatment options for AML, and many patients are able to achieve remission through treatment options including chemotherapy, bone marrow transplants, radiation therapy and targeted drug therapy.  Learn more about AML Treatment options here.

Approximately 60% to 70% of adults with AML can be expected to attain complete remission status after appropriate therapy.⁶  Age at diagnosis is an important criteria for remission rates, with an adverse relationship between age of diagnosis and remission.  

Yes, AML is a cancer of the bone marrow and blood that affects a patient’s ability to produce new, healthy blood cells.  Acute myeloid leukemia is the most common form of leukemia that develops in adult patients, and typically progresses rapidly if not treated.

AML (acute myeloid leukemia) is caused by a genetic mutation in the bone marrow that affects the stem cells ability to produce new blood cells (white blood cells, red blood cells and platelets).  The genetic mutation causes more blood cells than necessary to be created, however, the cells are typically immature instead of fully developed.  

As these immature cells increase in number, the symptoms of acute myeloid leukemia begin to show.  

What triggers the mutation is not currently known, however, there is a higher instance of AML in people with other blood disorders, genetic disorders, previous cancer treatments, radiation exposure and exposure to benzene.

Typical CBC results for a patient with AML show more white blood cells that are immature and fewer red blood cells and platelets than normal.  

The percentage of blasts (immature white blood cells) in the bone marrow or blood is usually examined for an AML diagnosis. If a patient has at least 20% blasts in the marrow or blood, they are diagnosed with AML. (In normal bone marrow samples, the blast count is 5% or less. The blood usually doesn’t contain any blasts.)  A healthy white blood count is in the range of 4,500 – 11,000 white blood cells per microliter of blood.