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Leustatin (Cladribine) - Summary

 

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WARNING

LEUSTATIN (cladribine) Injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Suppression of bone marrow function should be anticipated. This is usually reversible and appears to be dose dependent. Serious neurological toxicity (including irreversible paraparesis and quadraparesis) has been reported in patients who received LEUSTATIN Injection by continuous infusion at high doses (4 to 9 times the recommended dose for Hairy Cell Leukemia). Neurologic toxicity appears to demonstrate a dose relationship; however, severe neurological toxicity has been reported rarely following treatment with standard cladribine dosing regimens.

Acute nephrotoxicity has been observed with high doses of LEUSTATIN (4 to 9 times the recommended dose for Hairy Cell Leukemia), especially when given concomitantly with other nephrotoxic agents/therapies.

 

LEUSTATIN SUMMARY

LEUSTATIN®(cladribine)
Injection
For Intravenous Infusion Only

LEUSTATIN (cladribine) Injection (also commonly known as 2-chloro-2'-deoxy-(beta)-D-adenosine) is a synthetic antineoplastic agent for continuous intravenous infusion.

LEUSTATIN Injection is indicated for the treatment of active Hairy Cell Leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia or disease-related symptoms.

LEUSTATIN NEWS HIGHLIGHTS

Published Studies Related to Leustatin (Cladribine)

Cladribine alone and in combination with cyclophosphamide or cyclophosphamide plus mitoxantrone in the treatment of progressive chronic lymphocytic leukemia: report of a prospective, multicenter, randomized trial of the Polish Adult Leukemia Group (PALG CLL2). [2006.07.15]

Cladribine for multiple sclerosis: review and current status. [2005.11]

Comparison of cladribine plus prednisone with chlorambucil plus prednisone in patients with chronic lymphocytic leukemia. Final report of the Polish Adult Leukemia Group (PALG CLL1). [2005.10]

Addition of cladribine to daunorubicin and cytarabine increases complete remission rate after a single course of induction treatment in acute myeloid leukemia. Multicenter, phase III study. [2004.05]

Increased remissions from one course for intermediate-dose cytosine arabinoside and idarubicin in elderly acute myeloid leukaemia when combined with cladribine. A randomized population-based phase II study. [2003.12]

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Clinical Trials Related to Leustatin (Cladribine)

2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES) [Active, not recruiting]

Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab [Active, not recruiting]

Phase II Cladribine Add-on to Rebif New Formulation in MS Subjects With Active Disease (ONWARD) [Active, not recruiting]

CLARITY - Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-Remitting MS [Active, not recruiting]

Clarity Extension Study [Enrolling by invitation]

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Page last updated: 2006-11-04

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