Frequently Asked Questions

What is leukemia?

Leukemia is the general name for different cancers of the blood or bone marrow. In leukemia, white blood cells that have cancer grow and multiply in the bone marrow. Normal white blood cells help your body fight infection. Most patients with leukemia have very high numbers of white blood cells. These extra cells don’t work in a normal way. Over time, they crowd out normal blood cells and can keep them from working properly, too. Patients can also experience anemia (having too few red blood cells in the body), which typically causes a person to feel tired, weak, and short of breath because the body tissues are not getting enough oxygen. Another complication is a shortage of platelets, another type of cell in the blood, which is called thrombocytopenia. This condition may cause a person to bleed and bruise easily.

The way that people are affected by their cancer and how it spreads are different for each type of leukemia. Some leukemias grow fast ("acute leukemia") and others grow more slowly ("chronic leukemia"). Myeloid leukemias start from immature myeloid cells, a kind of white blood cell. Lymphocytic leukemias start from immature lymphocytes, another kind of white blood cell. Both kinds can grow quickly or slowly.

What is CLL?

In CLL, white blood cells (CLL cells) that aren’t normal do not stop normal blood cells from being made. This is why early stages of CLL are less severe than other forms of leukemia. Some patients with early-stage CLL have a high white blood cell count but no symptoms except maybe an infection that keeps coming back. During this time, healthcare professionals may “watch and wait” instead of giving treatment. “Watch and wait” means that healthcare professionals will watch for signs and symptoms of disease and wait until the disease progresses before treating it. The watch-and-wait stage can last many years in some patients. Other patients may need treatment right away or very soon.

What are the symptoms of CLL?

CLL patients often learn about their disease after a blood test during a routine checkup or when they have an infection. Many people with CLL do not have any symptoms when it is diagnosed. Sometimes, a person with CLL will find swollen lymph nodes in the neck, armpit, or groin and go to a healthcare professional. CLL symptoms can include:

• Feeling tired
• Weakness
• Fever
• Night sweats
• Shortness of breath
• Swollen lymph nodes (may be felt as lumps under the skin) or spleen (may feel like fullness in the belly)
• Repeated infections
• Weight loss for no reason
• Leukopenia
• Neutropenia
• Anemia
• Thrombocytopenia

What tests are used to diagnose CLL?

CLL is usually found by using more than one test, including any or all of the following.

Physical exam

Your doctor will check for swollen glands or lymph nodes.

Blood tests

A blood test shows the number of healthy white blood cells (lymphocytes) and unhealthy CLL cells. It also checks for the number of red blood cells and platelets. This is done by looking at blood cells under a microscope.

Aspiration/biopsy

Your doctor may take out a small sample of bone marrow from the back of the hip bone. This will help show the doctor how advanced the disease is.

Flow cytometry

This test looks for certain substances that are found on CLL cells. This helps identify what types of cells they are and determine if the CLL cells will respond to certain types of treatment. That information helps the doctor understand how the disease might progress, and whether the high lymphocyte count is caused by CLL.

Lab testing

Certain lab tests look at the DNA of blood cells under a microscope. Differences in the DNA can be seen by using a dye that shines under a certain light. Very often, some DNA is missing from CLL cells. The kind of DNA that is still there will give the doctor information he/she needs to know to help make treatment decisions.

Imaging

Imaging tests, such as CT scans and MRI, are used to see how much the disease has spread.

What are the stages of CLL?

Healthcare professionals may use Rai staging to find out the status of the disease and the health of the patient. Once the stage of the chronic lymphocytic leukemia (CLL) is known, the healthcare professional can choose the best treatment.

When staging, healthcare professionals look at:

• The number of CLL cells in the blood and bone marrow
• If the lymph nodes, spleen, or liver are bigger than normal
• If the patient has a low level of red blood cells (anemia)
• If the patient has a low level of platelets (thrombocytopenia)

What are the treatment options?

There are many choices for treating CLL. If one kind of treatment does not work, or if it works for a while and then your disease comes back, your doctor may try a different treatment.

The treatment choices may include:

Chemotherapy: A cancer treatment that uses drugs to stop the growth of cancer cells, either by killing the cells, or by stopping them from increasing in number.

Biologic therapy: A type of treatment that works with your immune system. Monoclonal antibody therapy is one type of biologic therapy used to treat CLL. It can help the immune system kill leukemia cells.

Radiation therapy: A treatment that uses high-energy X-rays or other types of radiation to kill cancer cells and keep them from growing.

What is the goal of treatment?

The goal of any treatment for CLL is to lower the amount or get rid of CLL cells in the blood and bone marrow.

What is TREANDA?

TREANDA is FDA-approved for the treatment of newly diagnosed CLL. TREANDA is a chemotherapy that has been shown to kill cells that cause CLL. TREANDA has a chemical structure that may help it kill cancer cells in many different ways. The exact way in which TREANDA kills cells is still being studied in laboratories.

In a clinical study that compared TREANDA to another drug called chlorambucil, the patients who received TREANDA had a better response to their treatment than the patients who received chlorambucil. The patients who received TREANDA had a longer response to treatment than chlorambucil before their leukemia returned.

The most common non-blood-related side effects (occurring in ≥15% of patients) with TREANDA are fever, nausea, and vomiting. The most common blood-related abnormalities (occurring in ≥15% of patients) with TREANDA include decreased red blood cells (anemia), decreased platelets (thrombocytopenia), decreased neutrophils (neutropenia), decreased lymphocyte cells (lymphopenia), and decreased white blood cells (leukopenia).

How is TREANDA given to treat CLL?

TREANDA is usually given to outpatients and is given through a needle that is put into a vein. This is called an intravenous (IV) infusion. The infusion lasts for 30 minutes and is given on Days 1 and 2 of each 28-day treatment cycle. TREANDA may be given for up to 6 cycles. Your doctor may need to change your dosing schedule if you experience side effects.

What can be expected after treatment with TREANDA?

After treatment with TREANDA, some patients may have no signs of CLL at all in their blood. This is called a complete response. Other patients may have a lower number of CLL cells or fewer symptoms of CLL. This is called a partial response. The total number of patients with complete response and partial response is known as the overall response rate. Some patients receiving TREANDA may have no response.

The most common non-blood-related side effects (occurring in ≥15% of patients) with TREANDA include fever, nausea, and vomiting. The most common blood-related abnormalities (occurring in ≥15% of patients) with TREANDA include decreased red blood cells (anemia), decreased platelets (thrombocytopenia), decreased neutrophils (neutropenia), decreased lymphocyte cells (lymphopenia), and decreased white blood cells (leukopenia).

What are the results of treatment with TREANDA?

In a clinical study, TREANDA was compared to chlorambucil. (Chlorambucil is another drug approved by the Food and Drug Administration to treat CLL.) Both medications were given without any other chemotherapy agents. There were 153 patients who took TREANDA, and 148 patients who took chlorambucil. Patients were 75 years old or younger, and were Binet stage B or C (Rai stages I-IV). Binet stage is another way of classifying how far the disease has progressed. None of the patients had ever been treated for their CLL.

In this clinical study, TREANDA provided a higher overall response rate vs chlorambucil. In fact, 59% of patients responded to TREANDA and 26% of patients responded to chlorambucil.

TREANDA also delayed "disease progression" in some patients, which means that the disease did not get worse for a noticeable period of time. Patients using TREANDA went a median of 18 months without their CLL getting worse versus 6 months with chlorambucil.

This number shows the "median" time of delayed disease progression. "Median" is the number where half of the patients experienced higher duration of response and half experienced lower duration of response.

What side effects may occur while I am taking TREANDA?

When chemotherapies kill cancer cells, they can also affect healthy blood cells. These healthy cells include red blood cells, platelets, and white blood cells. Some of the most common side effects occur when the number of healthy cells is lowered. Please talk about the possible side effects with your healthcare professional, which may include:

Allergic reactions: There is the possibility of mild or serious allergic reactions with TREANDA. Immediately report rash, facial swelling, or difficulty breathing during or soon after infusion because these symptoms may become severe or even life-threatening.

Myelosuppression: TREANDA may cause a decrease in white blood cells, platelets, and red blood cells. You will need frequent monitoring of your blood cells. Report shortness of breath, significant tiredness, bleeding, fever, or other signs of infection to your doctor because these symptoms may be severe and even life-threatening.

Pregnancy and nursing: TREANDA can cause harm to a fetus. Women should avoid becoming pregnant throughout treatment and for 3 months after TREANDA therapy has stopped. Men receiving TREANDA should use reliable contraception (birth control) throughout treatment and for 3 months after TREANDA therapy has stopped. Report pregnancy immediately. Avoid nursing while receiving TREANDA.

Fatigue: TREANDA may cause tiredness. Avoid driving any vehicle or operating any dangerous tools or machinery if you experience this side effect.

Nausea and vomiting: TREANDA may cause nausea and/or vomiting. You should report nausea and vomiting so that you can get treatment for these symptoms.

Diarrhea: TREANDA may cause diarrhea. You should report diarrhea to your healthcare provider so that it can be treated.

Rash: A mild rash or itching may occur during treatment with TREANDA. Immediately report severe or worsening rash or itching to your doctor.

Serious side effects have been associated with TREANDA, including myelosuppression (a reduced ability of the body to produce blood cells), infections, fever, chills, itching and severe allergic reaction, tumor lysis syndrome (rapid destruction of cancer cells), skin reactions including SJS/TEN, new cancers, and extravasation (drug escape from the vein during administration).

Some side effects, such as myelosuppression, infections, and SJS/TEN (when TREANDA was given at the same time as allopurinol and other medications known to cause SJS/TEN), have caused death. Your doctor will check you closely for these side effects and treat you quickly if they occur.

Some side effects may lead to the dose of TREANDA being lowered, stopped, or delayed.

TREANDA is not for patients with an allergy to bendamustine or mannitol. Women should not become pregnant while using TREANDA.

The most common side effects associated with TREANDA (frequency ≥15%) not related to blood are nausea, fatigue, vomiting, diarrhea, pyrexia (fever), constipation, loss of appetite, cough, headache, weight decreased, dyspnea (difficulty breathing), rash, and stomatitis (inflammation of the mouth). The most common side effects associated with TREANDA (frequency ≥15%) related to blood are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.

Please see full Prescribing Information.

How will my healthcare professional monitor me during treatment with TREANDA?

Your healthcare professional will ask you to have blood drawn to see how treatment is working. Your dose or your medications might be changed based on the results of this testing. These blood tests will show if you have low red blood cells, low white blood cells, and/or low platelets.

• Low red blood cells may make you feel tired, get tired easily, appear pale, and become short of breath
• Low white blood cells may give you a greater chance for infection. If you have a fever or other signs of infection, such as chills and coughing, call your doctor right away
• Low platelets give you a greater chance of bleeding. Call your doctor if you experience any unusual bleeding

Track your progress with the TREANDA Treatment Diary by writing down your blood counts and other notes.

How do I know if TREANDA is working?

While you are taking TREANDA, your healthcare team will want you to have physical exams, imaging tests (like CT or PET scans), and lab tests to track your health. They will know whether TREANDA is working if they see fewer CLL cells in these tests.

Track your progress with the TREANDA Treatment Diary by writing down your blood counts and other notes.