Glossary

Acute Lymphoblastic Leukemia (ALL): A rapidly progressive cancer that starts in a lymphocyte in the bone marrow. ALL is the most common form of childhood leukemia. The cancer cell multiplies and accumulates in the marrow as leukemic lymphoblasts. The lymphoblasts block normal blood cell-formation in the bone marrow, resulting in insufficient production of red cells, white cells and platelets.

Alopecia: Loss of hair, either on the head or all over the body. Alopecia can be caused by certain chemotherapy drugs. Clolar does not cause alopecia.

ANC: An abbreviation for absolute neutrophil count. This is the number of neutrophils (a type of white blood cell) found in the blood. The ANC is often low after chemotherapy.

Anemia: Low number of red blood cells.

Antiemetics: Medications that prevent or relieve nausea and vomiting.

B Cell: A type of lymphocyte (a specific type of white blood cell).

Blood Cell: A general term describing the three cellular components of blood (white blood cells, red blood cells, and platelets), all of which are made in the bone marrow.

Blood Count: A routine test to determine the amount of white blood cells, red blood cells, and platelets in a sample of blood. Also called complete blood count (CBC).

Bone Marrow: The soft, spongy tissue in the center of large bones that produces white blood cells, red blood cells, and platelets.

Bone Marrow Suppression: A condition in which the number of blood cells the body produces is greatly reduced.

Bone Marrow Transplantation (BMT): The process of replacing damaged bone marrow with healthy bone marrow from the patient (autologous BMT) or from a suitable donor (allogeneic BMT) to help restore the patient's immune system after chemotherapy and radiation.

Cancer: A general term for more than 100 diseases that are characterized by uncontrolled, abnormal growth of cells. Cancer cells can spread through the bloodstream and lymphatic system to other parts of the body.

Capillary Leak Syndrome (CLS): A side effect of chemotherapy in which fluid and proteins leak out of tiny blood vessels and flow into surrounding tissues. This can cause dangerously low blood pressure.

Chemotherapy: Treatment with anticancer drugs. The type of drugs used are determined by the type of cancer and the treatment determined by the doctor.

Clinical Trial: Research conducted with volunteer patients, usually to evaluate a new treatment, under strictly controlled conditions. Each trial is designed to answer scientific questions and to find better ways to treat individuals with a specific disease.

Combination Chemotherapy: The use of more than one drug to treat cancer.

Cytokine Release: A side effect of chemotherapy in which substances critical to the immune system are released and cause the body to respond as if it is battling a severe infection (see systemic inflammatory response syndrome [SIRS]).

Drug Resistance: The failure of (cancer) cells to respond to drugs (chemotherapy).

Graft-Versus-Host Disease (GVHD): A complication that may develop after a bone marrow transplant in which the lymphocytes from the donated bone marrow react against the body's cells.

Hand-Foot Syndrome: Also known as palmar-plantar erythrodysesthesia syndrome. A side effect of chemotherapy that causes tingling, redness, dryness, and flaking of skin on the hands and/or feet.

Hematologist: A doctor who specializes in the treatment of blood diseases.

Hyperuricemia: A side effect of chemotherapy in which high levels of uric acid form in the blood, due to rapid destruction of cells.

Hypotension: Low blood pressure.

Immune System: The system within the body that recognizes and fights foreign cells and disease.

Immunosuppression: Suppression of the immune response as a result of drugs (chemotherapy) or radiation.

Infusion: Administration of fluids or medications into the blood through the veins.

Intrathecal (IT): Into the spinal fluid.

Intravenous (IV): Within, or administered into, a vein.

Leukocyte: A white blood cell (WBC). There are 3 main types of leukocytes: monocytes, granulocytes or neutrophils, and lymphocytes.

Leukopenia: A low number of leukocytes or WBCs. Leukopenia decreases the body’s ability to fight disease and infections.

Lymphocytes: A type of white blood cell that fights infection and disease and are found in the bloodstream, the lymphatic system, and lymphoid organs.

Nausea: Feeling sick or wanting to vomit, possibly with dizziness or symptoms.  Some chemotherapy combinations can cause nausea for up to several days - this can be lessened by taking antiemetic drugs.

Neutropenia: A low number of neutrophils (a type of white blood cell); this condition may increase the risk of infection depending how low the neutrophil count is and for how long it has been low.

Neutrophil: A type of white blood cell that fights bacterial infection (also called a granulocyte).

Oncologist: A doctor who specializes in the study, diagnosis, treatment and rehabilitation of individuals with cancer.

Oncology: Study of the development, diagnosis, treatment, and prevention of cancer.

Palliative: Treatment designed to reduce the symptoms of a disease rather than to cure it.

Pediatric: Relating to children, childhood.

Platelet: A blood cell that helps to control bleeding by inducing clotting.

Pruritus: Itching.

Radiation Therapy: Treatment with high-energy radiation from X-rays or other sources of radiation.

Red Blood Cell (RBC): Blood cell that carries oxygen to the cells of the body and removes carbon dioxide. Low numbers of RBC is called anemia.

Refractory: Not responding to treatment.

Relapse: The return of symptoms and signs of a disease after a period of improvement.

Remission: The complete disappearance of cancer cells and symptoms. It does not always mean the individual has been cured.

Side Effect: Secondary effect caused by cancer treatment.

Systemic Inflammatory Response Syndrome (SIRS): A condition in which there is inflammation throughout the whole body. Patients with SIRS may experience fast heart rate, low blood pressure, low or high body temperature, and low or high white blood cell count.

T Cell: A type of lymphocyte that attacks any foreign substance in the body.

Thrombocytopenia: A low number of platelets/thrombocytes in the blood. It can cause spontaneous bleeding of gums or nose and bleeding of other tissues. Unexplained bruising of the skin is also characteristic.

White Blood Cell (WBC): A variety of cells that fight infection in the body and are part of the immune system. See leukocytes.

White Blood Cell Count: Measurement of the total number of white blood cells in a sample of blood.

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How Clolar is Used

Clolar is a type of medication to treat children, ages 1 to 21 with a type of leukemia called relapsed or refractory acute lymphoblastic leukemia (ALL), after at least 2 other treatment attempts have failed. Clolar can reduce the number of leukemia cells in the blood. At this time we do not know if Clolar will help a child with ALL live longer or cure him or her of the cancer.

Important Safety Information for Patients

Serious side effects

Clolar can cause serious side effects that include:

• Systemic inflammatory response syndrome (SIRS)/capillary leak syndrome (CLS). Signs include fast breathing, fast heartbeat, low blood pressure, and difficulty breathing. These signs should be reported to the physician right away, as SIRS and CLS can be life-threatening if not treated right way. If your child experiences clinically significant signs of SIRS or CLS, your physician should stop Clolar immediately and consider giving your child steroids, diuretics, and albumin. When your child has stabilized, Clolar can be continued, usually at a lower dose.
• Bone marrow suppression and infection. Clolar can stop your child’s bone marrow from making enough red blood cells, white blood cells, and platelets. Serious side effects can result from this, and include severe infection (sepsis), bleeding, and anemia.
• Effects on pregnancy and breastfeeding. Females should not become pregnant or breastfeed during treatment with Clolar because Clolar may harm the baby.

Other side effects

The most common side effects with Clolar are stomach problems (including vomiting, diarrhea, and nausea), and effects on blood cells (including low red and white blood cells count, low platelet count, fever, and infection). A fast heartbeat has been noted in some patients taking Clolar. Clolar can also affect the liver and kidneys. For these reasons, your child’s healthcare professional will do blood tests to monitor his or her blood cells, kidney function, and liver function.

Treatment with Clolar quickly reduces the number of leukemia cells in your child’s blood. For this reason, your doctor should monitor your child for signs and symptoms of tumor lysis syndrome (TLS), as well as signs and symptoms of cytokine release, which can develop into SIRS, CLS, and organ problems. Your doctor is encouraged to give continuous IV fluids throughout the five days of Clolar treatment to reduce certain side effects. Your doctor may also prescribe allopurinol to reduce the build-up of uric acid that occurs with TLS. Your doctor should stop the Clolar treatment if your child develops low blood pressure for any reason during the five days of treatment.

Please speak with your healthcare professional if you have questions about Clolar. Also, please see full prescribing information.