What is chronic lymphocytic leukemia?

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Chronic lymphocytic leukemia (CLL) is a type of blood cancer that involves lymphocytes—white blood cells that help fight infections. When you have CLL, abnormal lymphocytes build up in the blood and bone marrow. Over time, these abnormal cells crowd the healthy cells. The result is fewer healthy white blood cells, red blood cells, and platelets. This leads to problems such as infection, anemia, and excess bruising and bleeding. Abnormal lymphocytes may also build up in lymph nodes, the liver, or the spleen (an organ in your abdomen). This can lead to swelling of these organs.

Where CLL Develops in the Body

Diagram of where chronic lymphocytic leukemia (CLL) develops in the body

What are the symptoms of chronic lymphocytic leukemia (CLL)?

Everyone experiences CLL differently. CLL does not always cause symptoms. In early stages of CLL, you are less likely to be bothered by symptoms. Still, it is important to pay attention to how your CLL may be affecting you. Tell your doctor if you notice any symptoms or changes in your health.

The symptoms you should watch out for include:

  • Weakness
  • Feeling tired
  • Feeling short of breath
  • Weight loss
  • Fever
  • Night sweats
  • Enlarged lymph nodes (felt as lumps under the skin)
  • Pain or a sense of “fullness” in the belly (especially after eating a small meal)
  • Infections
  • Excess bruising and bleeding

Symptoms of CLL may be seen in other conditions as well. Only your doctor will be able to tell if your symptoms are related to CLL.

Your doctor may look for:

  • An increase in the number of abnormal white blood cells
  • A decrease in the number of normal blood cells
  • Swelling in your lymph nodes, liver, or spleen

Worsening of symptoms is reason to start treatment for CLL. Remember to talk with your healthcare team.

Understanding medical tests for chronic lymphocytic leukemia (CLL)

Chronic lymphocytic leukemia cannot be diagnosed by symptoms alone. In fact, you are often not the first to notice your CLL. CLL is usually detected by routine checkups, or blood work for other health issues. Your doctor will need to use medical tests to diagnose your CLL. Medical tests will also tell where CLL is in your body.

Common CLL tests for diagnosis or prior treatment:

  • Physical exam—your doctor checks for swollen lymph nodes, liver, or spleen and other signs of CLL
  • Blood cell counts—your blood is taken through a vein and examined in a lab. Most people with CLL have a high white blood cell count
  • Biopsy—a small sample of bone marrow or lymph node is removed and viewed under a microscope
  • Flow cytometry—a sample of your cells is examined using a laser beam and a computer to find out the type of cancer and the number of cells involved

Common tests to find out where CLL is in your body include:

Imaging tests such as CT scans—these are pictures of the inside of your body that help show where CLL is.

How do I know how advanced my chronic lymphocytic leukemia (CLL) is?

Your doctor may talk about your CLL as being a certain stage. Stages are a medical way for your healthcare team to talk about how advanced your cancer is. Your stage is based on how many CLL cells you have and where they are in your body. This translates into early, intermediate, or advanced CLL.

Staging and the presence of symptoms often help your medical team determine:

  • if treatment is necessary at this time, and
  • what the most appropriate treatment is

Stages of chronic lymphocytic leukemia

Early 0
  • High lymphocyte count in the blood
Intermediate I
  • High lymphocyte count in the blood
  • Swollen lymph nodes
Intermediate II
  • High lymphocyte count in the blood
  • Swollen spleen or liver
  • With or without swollen lymph nodes
Advance III
  • High lymphocyte count in the blood
  • Low red blood cell count (anemia)
  • With or without swollen lymph nodes, spleen, or liver
Advance IV
  • High lymphocyte count in the blood
  • Too few blood platelets
  • With or without anemia or swollen lymph nodes, spleen, or liver
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This is not meant to replace the advice of your healthcare team.

Important Safety Information and Indications


GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.

What is the most important safety information I should know about GAZYVA?

Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that can become serious or life-threatening, including:

  • Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If you have a history of hepatitis B infection, GAZYVA could cause it to return. You should not receive GAZYVA if you have active hepatitis B liver disease. Your doctor or healthcare team will need to screen you for hepatitis B before, and monitor you during and after, your treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes

  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. Your weakened immune system could put you at risk. Your doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems

Who should not receive GAZYVA?

  • Do NOT receive GAZYVA if you have had an allergic reaction (e.g., anaphylaxis or serum sickness) to GAZYVA. Tell your healthcare provider if you have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past

What are the additional possible serious side effects of GAZYVA?

Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that may become severe or life-threatening, including:

  • Infusion-Related Reactions (IRRs): These side effects may occur during or within 24 hours of any GAZYVA infusion. Some IRRs can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening IRRs. If you have a reaction, the infusion is either slowed or stopped until your symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the IRR is life-threatening, the infusion of GAZYVA will be permanently stopped. Your healthcare team will take steps to help lessen any side effects you may have to the infusion process. You may be given medicines to take before each GAZYVA treatment. Symptoms of IRRs may include: fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort

  • Hypersensitivity Reactions Including Serum Sickness: Some people receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, your doctor will stop the infusion and permanently discontinue GAZYVA

  • Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in patients receiving GAZYVA. GAZYVA works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart and may lead to kidney failure requiring the need for dialysis treatment. Your doctor may prescribe medication to help prevent TLS. Your doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness

  • Infections: While you’re taking GAZYVA, you may develop infections. Some of these infections may be fatal and severe, so be sure to talk to your doctor if you think you have an infection. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with GAZYVA

  • Low White Blood Cell Count: When you have an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While you are taking GAZYVA, your doctor will do blood work to check your white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If your white blood cell count is low, your doctor may prescribe medication to help prevent infections

  • Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA may reduce the number of platelets you have in your blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While you are taking GAZYVA, your doctor will do blood work to check your platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. If your platelet count gets too low, your treatment may be delayed or reduced

  • Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA. DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by your doctor as it can lead to uncontrollable bleeding

The most common side effects of GAZYVA in CLL were infusion-related reactions and low white blood cell counts.

What other information should I tell my doctor before receiving GAZYVA?

You should talk to your doctor about:

  • Immunizations: Before receiving GAZYVA therapy, tell your healthcare provider if you have recently received or are scheduled to receive a vaccine. People who are treated with GAZYVA should not receive live vaccines

  • Pregnancy: Tell your doctor if you are pregnant, think that you might be pregnant, or plan to become pregnant. GAZYVA may harm your unborn baby. Speak to your doctor about using GAZYVA while you are pregnant. Talk to your doctor or your child’s doctor about the safety and timing of live virus vaccinations to your infant if you received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after your GAZYVA treatment

  • Breastfeeding: Because of the potential risk of serious side reactions in breastfed children, women should not breastfeed while taking GAZYVA and for 6 months after your last dose

Tell your doctor about any side effects.

These are not all of the possible side effects of GAZYVA. For more information, ask your doctor or pharmacist.

GAZYVA is available by prescription only.

You may report side effects to the FDA at (800) FDA-1088, or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the accompanying full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.