38 results
Primary: To characterize the PK of nilotinib in pediatric patients with newly diagnosed CP Ph+ CML, with CP or AP Ph+ CML resistant / intolerant to imatinib and/or dasatinib, or with Ph+ ALL refractory/relapsed.Secondary:• To assess the safety and…
The main purpose of this study is to determine the rate of treatment-free molecular remission (MMR=MR3.0) after 48 weeks following start of the TFR phase. The study further seeks to provide evidence that suspending nilotinib therapy in these…
Primary: to evaluate the effectiveness of two treatment regimens by assessing the average stable maximum best-corrected (BCVA) change from Month 4 to Month 12 compared to Month 3. A treatment regimen will be considered a relevant treatment option if…
Primary: To demonstrate that intravitreal injection of 0.5 mg ranibizumab administered based on individual patient needs has superior efficacy compared to sham treatment in adult patients with visual impairment due to VEGF-driven ME. Secondary: Best…
To evaluate the effect of real-life food consumption on the pharmacokinetics of nilotinib in CML patients
To compare visual outcome and foveal function after (initiation of) treatment between patients receiving an RPE-choroid graft and patients with anti-VEGF medication.
Primary objectiveto demonstrate superiority of ranibizumab 0.5 mg as adjunctive or mono-therapy to laser treatment in the mean change from baseline in BCVA over a 12-month treatment period.Secondary objectives* to evaluate whether ranibizumab (0.5…
Primary objective* To evaluate ocular and non-ocular adverse events during the 24-months study period in patients treated with Lucentis (0.5 mg)Secondary objectives* To describe the ocular and non-ocular adverse events over a cumulative 36-months…
Primary* To compare the efficacy (Major Molecular Response, MMR, rate at 12 months) Secondary* To compare the rate of durable MMR at 24 months in patients with a MMR at 12 months* To compare the rate, time to and duration of complete cytogenetic…
Primary: to compare the treatment effect of ranibizumab PRN (visual acuity loss and/or SD-OCT disease activity guided retreatment) versus aflibercept bimonthly regimen on central retinal thickness stability as measured by mean fluctuations between…
Primary objective:* To assess the clinical efficacy of nilotinib, based on overall response rate (ORR), in thetreatment of c-Kit mutated melanoma in patients who have not received prior therapy withTKIs.Key secondary objectives:To assess the durable…
The main purpose of this study is to determine the rate of treatment-free molecular remission (MMR=MR3.0) after 48 weeks following start of the TFR phase. The study further seeks to provide evidence that suspending nilotinib therapy in these…
The primary objective is to evaluate the efficacy of an individualized stabilization criteriadrivenPRN dosing regimen with 0.5 mg ranibizumab as assessed by the mean best-corrected visualacuity (BCVA) change at Month 12 compared to Baseline.
Primary objectiveTo assess the efficacy of intravitreally (ITV) administered VEGF Trap-Eye compared to ranibizumab (in a non-inferiority paradigm) in preventing moderate vision loss in subjects with all subtypes of neovascular AMD Secondary…
Primary* To evaluate whether the efficacy of nilotinib is superior to the control arm (as measured by progression free survivalSecondary* To compare the response rate, and time to response, duration of response, and time to tumor progression of…
The primary objective of this study is to estimate the incidence of ocular adverse events in patients with CNV secondary to AMD who receive an individualized treatment with ranibizumab 0,3 mg.
Het objectives of the study are to demonstrate that combination therapy of Lucentis and Visudyne is not inferior in effectivity and safety to monotherapy with Lucentis and to investigate whether less Lucentis injections in combination therapy with…
To evaluate the CCyR rate at 12 months of nilotinib compared to imatinib in adult patients with Ph+ CML in CP who have a suboptimal cytogenetic response on imatinib.
The aim of the current study is to confirm the CMR rates of nilotinib in newly diagnosed CML-CP patients in a pan-European population using the EUTOS (*European Treatment and Outcome Study for CML*) standardised molecular laboratories. Secondary…
PRIMARY OBJECTIVEThe primary objective of the study will be to determine the efficacy of 12 weeks of nilotinib treatment as measured by the non progression rate (Complete response + Partial Response + Stable disease according to Response Evaluation…