NEWS HIGHLIGHTSMedia Articles Related to Leustatin (Cladribine)
Merck KGaA, FDA Grants Priority Review To Cladribine Tablets For The Treatment Of Relapsing Forms Of Multiple Sclerosis
Source: Multiple Sclerosis News From Medical News Today [2010.08.15]
Merck KGaA announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS). The application also has been granted a Priority Review designation by the FDA, which means the review period for the NDA is reduced...
EMD Serono, Inc, FDA Grants Priority Review To Cladribine Tablets For The Treatment Of Relapsing Forms Of MS
Source: Multiple Sclerosis News From Medical News Today [2010.08.07]
EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS). The application also has been granted a Priority Review designation by the FDA, which means the review period for the NDA is reduced...
FDA Grants Priority Review To Cladribine Tablets For The Treatment Of Relapsing Forms Of MS
Source: Multiple Sclerosis News From Medical News Today [2010.07.29]
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS)...
Eighty-Three Percent Of Surveyed Neurologists Are Familiar With Emerging MS Agents
Source: Multiple Sclerosis News From Medical News Today [2010.08.16]
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that 83 percent of surveyed physicians are familiar with Merck Serono/EMD Serono's oral cladribine and Novartis/Mitsubishi Tanabe's FTY-720/fingolimod/Gilenia (when all three names are surveyed) among the surveyed oral emerging therapies for the treatment o...
Published Studies Related to Leustatin (Cladribine)
Combination of cladribine and cytarabine is effective for childhood acute myeloid leukemia: results of the St Jude AML97 trial. [2009.08]
Because cladribine can increase cytarabine triphosphate levels, we tested a cladribine-cytarabine combination in the St Jude AML97, trial in which this combination was administered before standard chemotherapy to 96 children with acute myeloid leukemia (AML) or myelodysplastic syndrome... Our results suggest that cladribine in combination with continuous-infusion cytarabine is effective therapy for childhood AML.
Effect of parenteral cladribine on relapse rates in patients with relapsing forms of multiple sclerosis: results of a 2-year, double-blind, placebo-controlled, crossover study. [2009.06]
OBJECTIVE: This randomized, 2-year, double-blind, placebo-controlled, crossover study evaluated cladribine for relapsing forms of multiple sclerosis. DESIGN: Patients: (n = 84) received seven 5-day courses of subcutaneous cladribine at 5 mg/day (group A) or placebo (group B) in year 1; treatment was reversed in year 2.
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]
In this prospective randomized trial, we compared the efficacy and toxicity of cladribine (2-CdA) alone to 2-CdA combined with cyclophosphamide (CC) or cyclophosphamide and mitoxantrone (CMC) in untreated progressive chronic lymphocytic leukemia (CLL)... No important differences in efficacy and toxicity were found between CC and 2-CdA regimens.
Cladribine for multiple sclerosis: review and current status. [2005.11]
In the 1990s, cladribine was developed as an adenosine deaminase-resistant nucleoside analog with selective lymphotoxic specificity in the hope that it might become useful in the treatment of some lymphoid neoplasms and autoimmune disorders.The proposed study will be the first large multicenter randomized controlled clinical trial of oral cladribine in multiple sclerosis.
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]
CONCLUSIONS: 2-CdA+P is significantly more effective as a second-line treatment and re-treatment than Chl+P. However, we found a trend to longer survival in elderly patients treated with Chl+P.
Clinical Trials Related to Leustatin (Cladribine)
2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES) [Active, not recruiting]
Primary Objectives:
1. To determine the response rate, progression-free survival (PFS) and overall survival of
patients who receive 2-CdA + Ara-C.
2. To examine if there is any clonality in the cytokine expression of helper T cells or
cytokine receptor expression of eosinophils.
3. To determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils.
Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab [Active, not recruiting]
Primary Objectives:
1. To assess frequency and complete response in newly diagnosed patients with
Waldenstrom's macroglobulinemia treated with 2CdA, cyclophosphamide and rituximab.
2. To assess duration of unmaintained remission and frequency of recontrol with resumption
of treatment.
CLARITY - Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-Remitting MS [Active, not recruiting]
Clarity Extension Study [Enrolling by invitation]
The purpose of this extension trial is to further evaluate the safety and tolerability of
oral cladribine in subjects who have previously completed treatment within trial Protocol
25643.
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.
Primary Objectives:
1. To demonstrate the efficacy in achieving complete response of combination of Cladribine
administered intravenously over 2 hours for 5 days followed by Rituximab weekly for 8
weeks in patients with untreated or previously treated hairy cell leukemia.
2. To examine the efficacy of Rituximab to eradicate minimal residual disease (MRD) after
Cladribine therapy (as assessed by immunophenotyping of bone marrow and peripheral
blood).
3. To examine the effect of addition of Rituximab to Cladribine on the long term
disease-free (DFS) and overall survival (OS)(as compared with historical controls)
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