Click on the questions below to find out more about chronic lymphocytic leukemia (CLL) and treatment with TREANDA®.
Leukemia is the general name for different cancers of the blood or bone marrow. In leukemia, "abnormal," or cancerous, white blood cells grow and multiply in the bone marrow. 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, too.
The ways that people are affected by their cancer and the rate at which the cancer progresses are different for each type of leukemia. Some leukemias develop quickly ("acute leukemia") and others develop over a much longer period of time ("chronic leukemia"). Both acute and chronic myeloid leukemias develop from immature myeloid cells, a kind of white blood cell. Acute and chronic lymphocytic leukemias develop from immature lymphocytes, another kind of white blood cell.
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In CLL, the abnormal white blood cells (CLL cells) do not prevent normal blood cell production as much as with some other forms of leukemia. This is the reason that early stages of CLL are much less severe than other forms of leukemia. Some patients with early-stage CLL have a high white blood cell count but no symptoms except, perhaps, a recurring infection. During this period, healthcare professionals may "watch and wait" instead of prescribing treatment. "Watch and wait" means that healthcare professionals will watch for signs and symptoms of disease and wait until the disease progresses before starting treatment. The watch-and-wait stage can last for many years in some patients. Other patients may require treatment at the time of diagnosis or soon after diagnosis.
More people have CLL than any other form of leukemia. About 15,000 new cases of CLL are diagnosed in the United States every year. Most people with CLL are over 50 years old.
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CLL patients often learn about their disease after a blood test during a routine checkup or when they have an infection. Sometimes, a person with CLL will find enlarged lymph nodes in the neck, armpit, or groin and go to a healthcare professional. CLL symptoms can include:
- Fatigue
- Weakness
- Fever
- Night sweats
- Shortness of breath during normal activities
- Weight loss
- Swollen lymph nodes or spleen
- Repeated infections
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Common medical tests are used to diagnose illness, determine the stage of CLL, and to monitor treatment progress:
- Physical exam—to check for swollen lymph nodes and other signs of disease
- Blood tests—to assess the number of both healthy cells and CLL cells
- Bone marrow aspiration and biopsy—to show how cells have changed and how many CLL cells there are
- Flow cytometry—to see if the high lymphocyte count is caused by CLL. This test can also show if the CLL is T-cell or B-cell CLL. B-cell CLL is more common (95%)
- Laboratory testing—to see if chromosomes in CLL cells have changed. These changes can give healthcare professionals information that helps them treat individual patients
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Healthcare professionals may use Rai staging to indicate the status of the disease and the health of the patient. Once the stage and characteristics of the chronic lymphocytic leukemia (CLL) are determined, the healthcare professional can select the most appropriate treatment.
When staging, healthcare professionals consider:
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The goal of any treatment for CLL is to reduce or eliminate the CLL cells in the blood and bone marrow.
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TREANDA is a chemotherapy with alkylating properties, which means it can kill CLL cells. It has a unique design that combines 2 kinds of chemical structures. TREANDA can kill cancer cells by several biologic pathways. The way TREANDA works has been studied in the lab, but how it specifically works is still being investigated.
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TREANDA can be given in an outpatient setting, such as a clinic or oncology office. TREANDA is administered through a needle that is put into your vein. This process is called an intravenous infusion (IV). The infusion lasts for 30 minutes and is given on Days 1 and 2 of each 28-day treatment cycle. TREANDA can be given for up to 6 cycles.
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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 reduced number of CLL cells or reduced symptoms of CLL. This is called a partial response. Some patients may have no response to this treatment. The combined number of patients with complete response and partial response is known as the overall response rate.
TREANDA provided a significantly higher overall response rate vs chlorambucil,* another drug approved by the Food and Drug Administration to treat CLL; 59% of patients responded to TREANDA and 26% of patients responded to chlorambucil.
OVERALL RESPONSE TO TREATMENT*
In addition, TREANDA delayed "disease progression," which means that the disease did not get worse for a significant period of time. Patients receiving TREANDA went an average† of 18 months with no worsening of their CLL versus 6 months with chlorambucil.
DELAYED DISEASE PROGRESSION*
*In a clinical study, TREANDA was compared to chlorambucil. Both drugs were given without additional chemotherapeutic agents. There were 153 patients who took TREANDA, and 148 patients who took chlorambucil; patients were 75 years of age or younger and were Binet stage B or C (Rai stages I-IV). None of the patients had ever received treatment for their CLL.
†This number represents the "median" time of delayed disease progression. "Median" is a type of average.
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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 reduced. Please discuss the possible risks of side effects with your healthcare professional.
The most common non-hematologic adverse reactions associated with TREANDA (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis. The most common hematologic abnormalities associated with TREANDA (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.
Please see full Prescribing Information
Click here to find out more about talking to your healthcare professional about side effects.
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Your healthcare professional will ask you to have blood drawn to monitor therapy. You may have your dose adjusted or your medications changed based upon the results of this testing. These blood tests will identify 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 for bleeding. Call your doctor if you experience any unusual bleeding
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While you are taking TREANDA, your healthcare team will want you to have physical exams, imaging tests (such as CT or PET scans), and lab tests to measure your progress. They will know whether TREANDA is working based on the reduced presence of CLL shown in these tests.
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During treatment with TREANDA, it is important to avoid infections, manage fatigue, and eat well.
Tips that may help to avoid infections
- Talk to your healthcare professional about flu shots for you and your family prior to treatment
- Call your healthcare professional at the first sign or symptom of infection
- Use a thermometer if you think you have a fever, and call your healthcare professional if you do
- Talk to your healthcare professional about how to avoid any immunization with live viral vaccines, such as a flu nasal mist
- Wash your hands often
- Keep your body clean, especially your feet, groin, and armpits
- Avoid people with coughs, colds, or other infections
- Avoid large crowds
- Clean cuts or scrapes right away with soap and warm water
- Use an electric shaver instead of a razor, and don’t share it
- Avoid having manicures, pedicures, false nails, and nail tips
- Wash fruits and vegetables thoroughly
- Avoid unpasteurized milk, cheeses, or yogurt
- Make sure meat, poultry, fish, and eggs are thoroughly cooked
- Thaw meat in the refrigerator
- Avoid gardening
Tips that may help to manage fatigue
- Get enough rest and sleep, but remember:
- Too much rest can make you feel weaker
- Try short naps (1 hour) instead of long ones
- Stay as active as possible
- Exercise regularly, for example, by walking several times a week
- Talk to your healthcare professional before starting an exercise program
- Do gentle stretching exercises and isometrics
- Manage your energy levels
- Schedule activities when you have the most energy, and rest between them
- At home or work, take on only what you can manage; let others help
- Stay positive
- Picture yourself doing something you love
- Say to yourself, "I can create the energy I need"
- Learn relaxation techniques to slow your heart rate and calm your mind
Practice good nutrition
Good nutrition can help maintain your weight and fight infection. Your diet should include quality protein (fish, low-fat meat, eggs, and tofu). You should also eat more foods with iron, such as meats, leafy greens, and iron-fortified grains and cereals.
Talk to your healthcare professional about speaking to a dietitian or nutritionist about your diet.
Take an active role in your treatment
You can participate in the course of your treatment by recording your blood counts and making notes about wellness activities, side effects or any question you may have in your Treatment Diary. This will give you a record that you can easily share with your healthcare team. Together you can plan ways to manage your treatment and enhance your well-being.
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TREANDA for injection is indicated for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. TREANDA is also indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.
The following serious adverse reactions have been associated with TREANDA: myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions including SJS/TEN, other malignancies, and extravasation. Some of these reactions have been fatal, including myelosuppression, infections, and SJS/TEN (when TREANDA was administered concomitantly with allopurinol and other medications known to cause SJS/TEN). Patients should be monitored closely for these reactions and treated promptly if any occur. Adverse reactions may require interventions such as decreasing the dose of TREANDA, or withholding or delaying treatment. Myelosuppression is frequently severe and should be expected when treating patients with TREANDA.
TREANDA is contraindicated in patients with a known hypersensitivity to bendamustine or mannitol. Women should be advised to avoid becoming pregnant while using TREANDA.
The most common non-hematologic adverse reactions associated with TREANDA (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis. The most common hematologic abnormalities associated with TREANDA (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.
Please see full Prescribing Information.