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T-Cell Acute Lymphoblastic Leukemia (T-ALL)
Diagnosis
Since many of the symptoms of acute lymphoblastic leukemia (ALL) are not specific and may indicate other types of cancer or noncancerous problems, such as infections, an accurate diagnosis is needed. This section describes some of the tests that may be useful in diagnosing ALL.
Blood tests and biopsies
- Blood cell counts and blood cell examination (blood smear)—findings may suggest leukemia is present; however, usually a definite diagnosis cannot be made without obtaining a sample of bone marrow cells
- Bone marrow aspiration and biopsy—used for the initial diagnosis and to evaluate response to therapy
- Lumbar puncture—useful in determining if the leukemia has reached the brain or spinal cord
- Lymph node biopsy—important in diagnosing lymphomas, but is rarely needed for leukemias
Lab tests
- Cytochemistry, flow cytometry, immunocytochemistry—used to distinguish different types of leukemia from one another and from other diseases
- Cytogenetics and molecular genetic studies (eg, polymerase chain reaction, fluorescent in situ hybridization)—may help identify certain types of ALL by identifying DNA translocations; also important in determining prognosis
Imaging studies
Because leukemia does not usually form visible tumors, imaging tests (eg, chest X-ray, ultrasound, MRI scan, CT scan, gallium scan, bone scan) are of limited value. They are more commonly used to look for infections or other problems, rather than for the leukemia itself.
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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