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T-Cell Acute Lymphoblastic Leukemia (T-ALL)
Causes & Risk Factors
Most patients with leukemia do not have any known risk factors and therefore the exact cause of the disease is unknown. [4] The following section discusses some potential risk factors that have been linked to acute lymphoblastic leukemia (ALL).
Environmental toxins
Among environmental toxins, radiation exposure (both prenatal and postnatal exposure) has been shown to be a major risk factor for the development of ALL. In addition, one study suggested an increased risk of ALL in smokers older than 60 years. [4]
HTLV-1
Infection with the human T-cell lymphoma/leukemia virus (HTLV-1) can cause a rare type of ALL. Burkitt's lymphoma, which  has been linked to infection with the Epstein-Barr (EB) virus, is another type of infection that can form a type of ALL. However, these diseases are not common in the United States. [10]
DNA translocations
DNA translocations can cause leukemia. The most common translocation seen in ALL is known as the “Philadelphia chromosome,” which is a translocation between chromosomes 9 and 22. It occurs in about 20% to 25% of cases of ALL. Other chromosome changes, such as deletions and inversions, can also affect the development of ALL, although they are much rarer. Although inherited DNA mutations can increase the risk of many cancers, ALL is rarely caused by these. [11]
Hereditary factors
There are several inherited diseases that increase a child’s risk of developing leukemia. These include Li-Fraumeni syndrome, Down syndrome, and Klinefelter syndrome. Several other genetic disorders (neurofibromatosis, ataxia telangectasia, Wiskott-Aldrich syndrome, Bloom’s syndrome, Shwachman syndrome, and Fanconi anemia) also carry an increased risk of developing leukemia, but more commonly lead to non-Hodgkin’s lymphoma and other types of cancers. [10]
Immunodeficiency
Patients who are receiving intensive therapy to suppress their immune function (ie, transplant patients) and patients treated for other cancers with radiation therapy and chemotherapy have a higher risk of developing a second cancer later in life. The drugs most often implicated in therapy-related leukemias (mainly the myeloid type) include alkylating agents and topoisomerase II inhibitors. [4]
Indication
ARRANON is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.
Important Safety Information
ARRANON® (nelarabine) injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. This product is for intravenous use only.
Neurologic Events: Severe neurologic events have been reported with the use of ARRANON. These events have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of events associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.
Full recovery from these events has not always occurred with cessation of therapy with ARRANON. Close monitoring for neurologic events is strongly recommended, and ARRANON should be discontinued for neurologic events of NCI Common Toxicity Criteria grade 2 or greater.
In clinical studies of ARRANON, hematologic toxicity was the most common grade 3 (moderate) or 4 (severe) adverse event. For a complete list and incidence of adverse events: pediatric patients; adult patients. Hematologic toxicity included neutropenia, thrombocytopenia, anemia, febrile neutropenia, or neutropenia with infection.
Other common toxicities included laboratory abnormalities including increased transaminases, gastrointestinal toxicity, fatigue, and asthenia.
Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation may be at increased risk for neurologic adverse events.
Women of child-bearing potential should be advised to avoid becoming pregnant while receiving treatment with ARRANON.
Appropriate measures (e.g., hydration, urine alkalinization, and prophylaxis with allopurinol) must be taken to prevent hyperuricemia of tumor lysis syndrome.
Nursing should be discontinued in women who are receiving therapy with ARRANON.
Because the risk of adverse reactions to this drug may be greater in patients with severe renal impairment (CLcr <30 mL/min), these patients should be closely monitored for toxicities when treated with ARRANON.
Because the risk of adverse reactions to this drug may be greater in patients with severe hepatic impairment (bilirubin >3.0 mg/dL), these patients should be closely monitored for toxicities when treated with ARRANON.
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