B-CLLB-Cell Chronic Lymphocytic Leukemia
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7 molecules and proliferation associated Ki-67 molecules in B-CLL cells from 10 patients treated with VA-E for 12 months by flow cytometry.
Chlorambucil is a chemotherapy drug that has been used extensively in first-line treatment of B-CLL.
Patients with 13q deletion, a common genetic event seen in patients with B-CLL, had a statistically significant CR and ORR to MabCampath treatment.
Fludara (fludarabine phosphate) is approved as a first-line and second-line therapy in Europe for the treatment of B-CLL.
Presented at the 48th Annual Meeting of the American Society of Hematology (ASH) conference last year, data supporting the sBLA were part of an international Phase III clinical trial comparing Campath with chlorambucil in previously untreated patients with B-CLL.
Submission of this sBLA is based on positive data from a phase III clinical trial, which showed first-line treatment of B-CLL with Campath resulted in significantly better efficacy with a manageable safety profile as compared to chlorambucil," stated Mark Enyedy, senior vice-president and general manager of Genzyme's oncology business unit.
The international open-label, randomized trial with 297 enrolled patients compared the efficacy and safety of Campath to chlorambucil, which is considered by many to offer the most tolerable safety profile among agents commonly used for previously untreated B-CLL patients.
1) These data showed alemtuzumab (Campath(R), MabCampath(R)) was superior to chlorambucil as a first-line therapy with respect to progression free survival (PFS) in previously untreated patients with B-CLL.
In this phase II study -- the first to report clinical activity of lenalidomide in patients with CLL -- 45 patients with relapsed or refractory B-CLL were treated with a daily dose of 25 mg of lenalidomide.
A randomized, controlled phase 3 trial demonstrating clinical benefits in previously untreated patients with B-CLL has been completed, and final safety and efficacy results have been submitted for presentation at a medical meeting later this year.
It is well known that p53 mutations and deletions are associated with poor survival in B-CLL patients," said hematologist/oncologist Mark Goldberg, M.
Apoptosis is stimulated in vitro, when B-CLL cells were incubated with mistletoe naive patient's serum.