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T-Cell Acute Lymphoblastic Leukemia (T-ALL)
Treatment
Certain prognostic factors help guide the decision of whether to initiate standard or more intensive treatment in patients with acute lymphoblastic leukemia (ALL). Some of these factors include age at diagnosis, initial white blood cell count, cytogenic test results, and initial response to diagnosis.
The four phases of treatment for ALL include remission induction, consolidation, maintenance therapy, and CNS prophylaxis, which is necessary since ALL often spreads to the CNS.
The induction chemotherapy regimen in adults will usually include all or some of the following agents: cyclophosphamide, vincristine, dexamethasone or prednisone, L-asparaginase, and  doxorubicin or daunorubicin. Methotrexate, cytarabine, or etoposide may also be added to some regimens.
The consolidation phase will include intermittent treatment with a regimen similar to the induction therapy. The medications may be given as a single course over one month or up to three courses over three months.
Maintenance treatment will include methotrexate and 6-mercaptopurine, often combined with vincristine and prednisone. This phase lasts about 2 years. The maintenance phase may not be necessary for certain types of leukemias,
such as T-cell ALL.
CNS prophylactic therapy typically includes intrathecal administration of methotrexate and cytarabine. Cranial radiation may be added as well.
In patients who do not respond to treatment, newer or more intensive doses of drugs may be tried. If relapse occurs, a stem cell transplant may also be considered.
Children [11]
Induction therapy will usually include L-asparaginase, vincristine, and a steroid (usually dexamethasone) for one month. A drug from the anthracycline class (eg, daunorubicin) may be added in high-risk patients.
The consolidation phase, which lasts 4 to 8 months, usually consists of methotrexate and 6-mercaptopurine or 6-thioguanine. Vincristine and prednisone may also be added. In high-risk patients, L-asparaginase, doxorubicin, cyclophosphamide, and cytarabine are often used and dexamethasone is used in place of prednisone.
Most treatment regimens for the maintenance phase include methotrexate and 6-mercaptopurine plus vincristine and a steroid.
CNS prophylactic therapy typically includes intrathecal administration of methotrexate. Hydrocortisone and cytarabine with or without cranial radiation are often added in high-risk patients.
The most commonly used drugs in patients who relapse include vincristine, L-asparaginase, anthracyclines, cyclophosphamide, cytarabine, and epipodophyllotoxins. Vincristine and a steroid will also be added. Finally, a stem cell transplant may be considered.
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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