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T-Cell Acute Lymphoblastic Leukemia (T-ALL)
Acute lymphoblastic leukemia (ALL), also called acute lymphocytic leukemia, is a malignant neoplasm of lymphocytes. The blood cells are arrested in the lymphoblast stage of the normal maturation pathway and accumulate in the bone marrow. [4] ALL can be divided into B-precursor ALL and T-cell ALL. Click here to learn more.
ALL is the most common malignant disease in children and adolescents; however, it accounts for only approximately 20% of acute leukemias in adults. [4] It was estimated that 3,970 new cases (1,300 adult cases) of ALL would be diagnosed in 2005. [5] In addition, it was estimated that approximately 1,490 people in the United States would die of ALL  during 2005, with two thirds of them being adults. [6]
The incidence in children peaks between the ages of 2 years and 5 years, with a median age at diagnosis of 11 years. [7] The risk of ALL is lowest between the ages of 25 years and 50 years and then begins to increase. [6]
- The disease is more common in Caucasians than in African Americans [4]
- The incidence appears to be highest in Hispanics [4]
- Slightly more common in males than in females [4]
Any organ system can become involved once leukemia cells enter the bloodstream; however, the lymph nodes, spleen, liver, central nervous system, and skin are the most common sites detected clinically. [4]
The overall 5-year relative survival rate for 1995-2001 was 64.6%. [5] The 5-year survival rate for ALL in children has greatly increased over time and is currently 80% to 85%. [8] In adults with ALL, it is 40%. [8]
Learn about the subtypes of acute lymphoblastic leukemia
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.
Prescribing Information for ARRANON | Important Safety Information | Patient Information Leaflet
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