19 results
Primary objectives-Determine efficacy, defined as PFS and OS at 2 years of risk-adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma patients 18-75 years.-Determine feasibility, defined as > 60% of cycles of the DA-EPOCH-R scheme on an out…
In this study we want to investigate whether the submission of zoledronic acid to neoadjuvant chemotherapy benefits the pathological complete response, and thus favors a better clinical outcome in patients with large ressectable or locally advanced…
To study in healthy human volunteers safety of the iPill system. Secondary objectives are recording of pH and temperature of the gastrointestinal tract. To investigate the measurement and communication functionality of the iPill system
Phase IIb: To evaluate the most effective dosing schedule of trabectedin.Phase III: To evaluate whether trabectedin given as 1st line chemothearpy for advanced/metastatic soft tissue sarcoma prolongs progression free surivival, as compared to…
We estimate that the anthracycline and cyclophosphamide dose could be significantly (>=15%) increased in at least 15% of ACC-treated patients. Therefore, in order to diminish the risk of under-dosing ACC, we aim to develop a neutrophil-guided…
The goal of the current study is to investigate the correlation of IntelliCap generated environmental information (gastrointestinal pH and temperature) with an established nuclear imaging technique. In addition, the functionality of the IntelliCap…
The objective of this trial is to evaluate the activity and safety of Brostallicin used as first line chemotherapy in patients with advanced or metastatic soft tissue sarcoma.
The aim of the trial is to individualize treatment for each patient by adapting it to early response and thus to continue intensive treatment only with those patients wo show an inadequate treatment response.For patients who show a good initial…
Primary Objective: * To make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen in patients with platinum sensitive recurrent HGSOC with mutated p53.Secondary Objective: * To assess the safety…
The aim of this trial is to individualize and thus to optimize treatment for each patient by adapting it to the individual response. The treatment response is determined by means of FDG-PET after 2 cycles of escalated BEACOPP + 2 cycles of ABVD.The…
Primary objective:To determine whether there is a difference in overall survival (OS) between lurbinectedin (PM01183)/doxorubicin (DOX) and a control armconsisting of best Investigator's choice between cyclophosphamide (CTX), doxorubicin (DOX)…
The primary objective of the study is to assess the incidence of pathological complete response (pCR) in breast and ipsilateral axillary tissue after daily treatment with veliparib in combination with neoadjuvant carboplatin and paclitaxel followed…
Protocol section 2.1 and 2.2
The primary objective is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) and T-cell ALL as measured by the complete response (CR) rate.The secondary…
Main objectiveThe primary objective of this study is to assess whether a higher HRQoL, in terms of impact of the disease and its treatment on physical and role functioning, is achieved with metronomic schedules of doxorubicin or cyclophosphamide…
The primary objective is to estimate the effect of spesolimab compared to placebo for the mean percent change from baseline in total abscessand inflammatory nodule count at Week 12. Secondary objectives are the evaluation of efficacy of spesolimab…
To demonstrate that spesolimab is effective in maintaining Symptomatic Stenosis Responseand / or inducing Radiographic Stenosis Response (defined in Table 2.3: 1) in patients withsymptomatic CD-related small bowel stenosis, who have achieved…
The primary objective of the trial is to demonstrate a non-flat curve and evaluate the doseresponse relationship for 3 subcutaneous dosing regimens of BI 655130 (spesolimab) (with each regimen consisting of a single loading dose and a separate…
The primary objective of this trial is to assess the long-term safety of spesolimab in patients with HS who have completed the 1368-0052 PoCC trial and are qualified for entry into this trial. The secondary objectives are to evaluate efficacy at a…