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.
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.
Published Studies Related to Leustatin (Cladribine)
Reduction in Healthcare and Societal Resource Utilization Associated with Cladribine Tablets in Patients with Relapsing-Remitting Multiple Sclerosis: Analysis of Economic Data from the CLARITY Study. [2012.01.01]
Background: Multiple sclerosis (MS) is a common, chronic, neurodegenerative condition associated with substantial healthcare and societal economic burden... Conclusion: This study provides evidence that the efficacy of cladribine tablets observed during the CLARITY study was associated with a reduced consumption of healthcare resources and a decreased need for medical and societal support.
Safety and tolerability of cladribine tablets in multiple sclerosis: the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study. [2011.05]
BACKGROUND: Cladribine is a synthetic deoxyadenosine analogue in development as an oral multiple sclerosis (MS) therapy. OBJECTIVE: To report in detail the safety findings from the 96-week, phase III, double-blind CLARITY study, which evaluated treatment with cladribine tablets in relapsing-remitting MS... CONCLUSION: The safety and tolerability profile observed in the CLARITY study together with the reported efficacy support the potential for cladribine tablets as an MS therapy.
Comparison of cladribine plus cyclophosphamide with fludarabine plus cyclophosphamide as first-line therapy for chronic lymphocytic leukemia: a phase III randomized study by the Polish Adult Leukemia Group (PALG-CLL3 Study). [2010.04.10]
PURPOSE Little is known about comparison of the activity of different purine nucleoside analogs in chronic lymphocytic leukemia (CLL). We conducted a randomized phase III trial to compare efficacy and safety of cladribine and fludarabine, each combined with cyclophosphamide, in previously untreated progressive CLL...
A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. [2010.02.04]
BACKGROUND: Cladribine provides immunomodulation through selective targeting of lymphocyte subtypes. We report the results of a 96-week phase 3 trial of a short-course oral tablet therapy in patients with relapsing-remitting multiple sclerosis... CONCLUSIONS: Treatment with cladribine tablets significantly reduced relapse rates, the risk of disability progression, and MRI measures of disease activity at 96 weeks. The benefits need to be weighed against the risks. (ClinicalTrials.gov number, NCT00213135.) 2010 Massachusetts Medical Society
Infectious complications in patients with acute myeloid leukemia treated according to the protocol with daunorubicin and cytarabine with or without addition of cladribine. A multicenter study by the Polish Adult Leukemia Group (PALG). [2010.02]
OBJECTIVES: The addition of cladribine to the standard regimen consisting of daunorubicin and cytarabine has been reported to increase the efficacy of induction therapy in acute myeloid leukemia (AML). The goal of this study was to determine the effect of this modification on the incidence and spectrum of infectious complications... CONCLUSIONS: The addition of cladribine to standard induction chemotherapy has no impact on the incidence and spectrum of infectious complications in newly diagnosed AML patients. Copyright 2009 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
Clinical Trials Related to Leustatin (Cladribine)
Allogeneic Transplantation Using Timed Sequential Busulfan, Cladribine, and Fludarabine Conditioning in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) [Recruiting]
The goal of this clinical research study is to compare how well two different schedules of
giving busulfan with fludarabine and cladribine before a stem cell transplant in patients
with AML or MDS may help to control the disease. The safety of this drug combination will
also be studied.
Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With Acute Myeloid Leukemia (AML), High Risk Myelodysplastic Syndrome (HR MDS) or Myeloid Blast Phase of Chronic Myeloid Leukemia (CML) [Recruiting]
The goal of this clinical research study is to learn if the combination of cladribine,
idarubicin, and cytarabine can help to control AML, high risk MDS, and/or CML in blast
phase. The safety of these drugs will also be studied.
Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) [Recruiting]
The goal of this clinical research study is to learn if cladribine given in combination with
low-dose cytarabine (LDAC) and decitabine can help control the disease in patients with AML
or MDS. The safety of this drug combination will also be studied.
Cladribine is designed to interfere with the cell's ability to process DNA (the genetic
material of cells). It can also insert itself into the DNA of cancer cells to stop them
from growing and repairing themselves.
Cytarabine is designed to insert itself into DNA of cancer cells to stop them from growing
and repairing themselves.
Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die.
2CDA With Rituximab in Hairy Cell Leukemia [Recruiting]
The goal of this clinical research study is to learn if treatment with 2CDA (cladribine)
followed by treatment with rituximab can help to control HCL. The safety of this combination
treatment will also be studied.
Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab [Active, not recruiting]
The goal of this clinical research study is to see how well the drugs 2CdA,
cyclophosphamide, and rituximab (rituxan) shrink a lymphoma called Waldenstrom's
macroglobulinemia. After these drugs are given for 2 courses, a second goal is to see how
long a remission lasts. A third goal is to see how often repeat remissions can be achieved
when the lymphoma returns later and the same drugs are restarted.
Reports of Suspected Leustatin (Cladribine) Side Effects
Blood Creatinine Increased (5),
Drug Ineffective (3),
Liver Function Test Abnormal (3),
Flushing (3), more >>
Page last updated: 2011-12-09