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"In these patients, bone marrow myeloid hyperplasia and an elevated myeloid and erythroid cells, and platelets in the peripheral blood were observed . This translocation was identified in more than 90% of the CML patients [3,4] and the variant/complex translocation was observed in 5-8% of cases with an involvement of additional third, fourth or fifth chromosome . "
"CML can affect any age group, but is predominant in elderly . In the majority of cases (~85%), patients are in the chronic phase of CML at the time of diagnosis . The survival rate of CML patients has shown noticeable improvement owing to earlier diagnosis and treatment with allogeneic bone marrow transplantation or interferon-α (IFN-α). "
[Show abstract][Hide abstract]ABSTRACT: Purpose:
This study was designed to characterize the pharmacokinetic profile and to assess bioequivalence of the sponsor's Test formulation (Imatinib Mesylate 400 mg tablets) with an innovator product (Gleevec® 400 mg tablets, Novartis Pharmaceuticals) under fed conditions, in adult patients of Philadelphia chromosome positive Chronic Myeloid Leukemia (Ph+ CML) stabilized on Imatinib mesylate 400 mg. In addition, the aim of this study was to monitor the safety profile of Investigational Medicinal Products (IMPs).
Materials and methods:
A multicenter, randomized, open label, two-period, crossover, single dose bioequivalence study was designed for conduct under fed conditions in 42 adult Ph+ CML patients already stabilized on Imatinib 400mg tablets. Pharmacokinetic parameters Tmax, Cmax, and AUC0-24 were calculated using a Non-compartmental model on validated WinNonlin software. Validated SAS software was used for statistical evaluation of data. The safety profile of investigational products was monitored during the course of study by applying a clinical process for recording observed untoward effects post administration of investigational products.
The 90% confidence intervals for the Test/Reference mean ratios of the ln-transformed PK variables Cmax (99.0%) and AUC0-24 (99.2%) were within an acceptable range of 80-125 %, as per bioequivalence assumptions. Both formulations were well tolerated after oral administration of Investigational Medicinal Products.
The Test product was found to be bioequivalent and safe, and thus can be used interchangeably in clinical practice.
Preview · Article · Feb 2016 · Cancer Research and Treatment
"Because of our patient's relatively unremarkable leukocyte count, this led to the suspicion that the grossly elevated number of platelets was responsible for her symptoms. Indeed, thrombocytosis exceeding 600,000/microL can be present in CML ; however, platelet counts exceeding 2,000,000/microL are rare and may be related to the patient's previous splenectomy . In addition, she presented with vasomotor instability and NSTEMI, which have been reported in the literature for essential thrombocytosis but not well described for CML . "
[Show abstract][Hide abstract]ABSTRACT: Chronic myeloid leukemia (CML), a hematologic malignancy characterized by unregulated growth of myelogenous leukocytes, typically presents with symptoms of fatigue, anorexia, and splenomegaly. Laboratory studies often reveal a significant leukocytosis with neutrophilia. A moderate thrombocytosis may be present, but is not usually problematic. The following case discusses a patient who presented with syncope, a convulsive episode, and non ST-segment myocardial infarction secondary to symptomatic thrombocytosis of 2.5 million cells/microL. She was treated with plateletpheresis and subsequently experienced resolution of symptoms. Ultimately, a diagnosis of CML with an atypical presentation of the disease was identified in this patient.