Autologous stem cell transplantation (ASCT) is considered standard therapeutic approach for patients with relapsed and refractory (R/R) diffuse large B cell lymphoma (DLBCL) that are transplant eligible. For transplant ineligible patients there are few therapeutic options and novel targeted therapies and immunotherapy that are still in development. Treatment of such patients with poor prognosis is considered to be a challenge and there is constant need for new salvage treatment regimens. The aim of this study was to evaluate patients’ characteristics and treatment strategies and considerations for diffuse large B cell lymphoma in our department, and to promote new therapeutic possibilities for R/R patients with NHL DLBCL. A total of 308 patients with NHL were treated at University Clinic for hematology from 2008 until 2020 and 49% (151) of patients with NHL DLBCL were included in this study. Survival analysis of all analyzed relapsed/refractory NHL patients revealed statistically significant better survival in patients with low risk IPI score, disease stage I/II and patients with age <60 years. R-CHOP was superior treatment as first line regimen and in the R/R patients, ASCT was statistically superior to other available second line treatment options. Overall survival in patients with DLBCL that achieved complete response after initial treatment was 80%. The incidence of disease relapse after initial treatment in the first 12 months was 18%. Overall survival in all treatment groups was 60% in the evaluated period of 2.5 years follow up. A total of 60% of patients with relapsed forms of NHL DLBCL were candidates for treatment with high-dose chemotherapy and ASCT. Other 40% patients were not candidates for ASCT. In conclusion we confirm the need for new treatment options for patients that relapse after ASCT and that are transplant ineligible. Patients and disease characteristics can be used to identify high-risk patients, classify once relapsed patients and define decision on further treatment.
Reactive oxygen species (ROS) are oxygen-containing radicals essential for cell signaling and other vital physiological functions. However, their increased production to an excessive amount can cause alterations in the cellular redox status with consecutive disruption of various normal biological functions.Oxidative stress (OS) occurs when there is an imbalance between ROS production and antioxidant defence mechanisms.Chronic OS results in many DNA modifications, and alterations in DNA repair, leading to DNA lesions of which many can be toxic and/or mutagenic. It is proven that OS is involved in the pathogenesis of chronic myeloid leukaemia (CML), a myeloproliferative neoplasm characterized by uncontrolled proliferation of maturing and mature myeloid cells, caused by the presence of translocation t(9;22) leading to the abnormal BCR-ABL fusion protein.Historically treatment options for this disease were limited, with allogeneic stem cell transplant being the only potential curative therapy, but still with poor prognosis. Fortunately, the introduction of tyrosine kinase inhibitors (TKIs) changed dramatically the prognosis of CML patients, turning a once fatal disease, into a chronic and manageable disorder. Analysis of CML patients treated with TKIs revealed a potential correlation between toxic effects of TKIs and levels of ROS.Even though the innovation of this therapy has significantly improved the life expectancy CML patients, still, in some cases, this treatment becomes ineffective.In order to clarify these observations, we measured and correlated the level of oxidative stress between healthy individuals and patients with chronic myeloid leukemia (CML) treated with first generation tyrosine kinase inhibitors (TKIs).The two markers of oxidative stress, d-ROMs and OSI were significantly higher in the group of patients with CML compared to healthy subjects. No statistically significant differences were observed between CML patients and healthy subjects regarding the oxidative stress marker PAT.
Zolpidem is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, pyrrolopyrazines, pyrazolopyrimidines or other drugs with known hypnotic properties. Zolpidem as conventional tablets is used as a hypnotic agent in the short-term management of insomnia, generally for periods not exceeding 7–10 days in duration. The objective of this study was to evaluate and compare the relative bioavailability, and therefore the bioequivalence of Zolpidem 10 mg test formulation versus a reference Zolpidem 10 mg formulation, following a single dose administration under fasting conditions The study was a single center, open, single dose, randomized, two - way crossover study in healthy male volunteers with a wash - out period of one week between study periods. Twenty-eight male healthy volunteers, aged 20-49 years were included into study. Blood samples for determination of zolpidem plasma concentrations were withdraw at 0 (pre-drug administration), 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-drug. The zolpidem concentrations in plasma were determined with HPLC, using fluorescence detection. The test formulation of zolpidem, dosed at 10 mg is bioequivalent for primary zolpidem parameters (Cmax, AUC0-t and AUC0-∞) to the reference formulation after a single oral administration of 10 mg zolpidem. Both medications are well tolerated with no serious adverse events. Thus, in view of the clinical use, both formulations are exchangeable without restrictions. Keywords: Zolpidem, bioavailability, bioequivalence study, single-dose
Clarithromycin is a semi-synthetic macrolide antibiotic, chemically 6-0-methylerythromycin, formulated as immediate-release tablets, extended-release tablets, and granules for oral suspension. The objective of this study was to evaluate and compare the relative bioavailability, and therefore the bioequivalence of Clarithromycin 500 mg test formulation versus a reference Klacid® forte 500 mg formulation, following a single dose administration under fasting conditions. The study was a single center, open, single dose, randomized, two-way crossover study in healthy male volunteers, with a wash-out period of one week between study periods. Twenty-four male healthy volunteers, aged 18-49 years were included into study. Blood samples for determination of clarithromycin and 14-OH clarithromycin concentrations were withdrawn at zero (pre-drug administration), 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 and 36 hours post-drug administration. The determination of clarithromycin and 14-OH clarithromycin concentrations in plasma was performed using validated LC/MS/MS method and internal standardization after liquid/liquid extraction with methyl t-butyl ether. The test formulation of clarithromycin, dosed at 500 mg is bioequivalent for primary clarithromycin and 14-OH clarithromycin parameters (Cmax, AUC0-t and AUC0-∞) to the reference formulation after a single oral administration of 500 mg clarithromycin. Both medications were well tolerated with no serious adverse events. Thus, in view of the clinical use, both formulations are exchangeable without restrictions. Keywords: clarithromycin, 14-OH clarithromycin, bioavailability, bioequivalence study, single-dose
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