23 results
The primary objective of the trial is to evaluate whether L-BLP25 administered as weekly subcutaneous vaccinations with or without pretreatment with intravenous cyclophosphamide (CPA) induces a change in immune response parameters (ELISpot against…
To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of nelarabine, etoposide and cyclophosphamide when given in combination to children with T-ALL and bone marrow relapse or T-LL.
The purpose of the study is to investigate the maximum effect of ADASUVE on repolarization of the heart. This is the process where the cells of the heart muscle recharge again after contraction. If this process is strongly slowed down, (potentially…
Phase 1Primary objective- To determine the maximum tolerated dose (MTD) and recommended phase 2 dose level (RDL) of lenalidomide administered during 21 days of a 4 week cycle, combined with continuous cyclophosphamide and prednisone. See paragraph…
Primary: Phase I part 1) Assessment of the recommended dosing and schedule for metronomic cyclophosphamide when administered in combination with fixed dose (10 mg) oral everolimus in patients with mRCC with respect to the selective induction of CD4+…
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus for 9 months (6 months of full therapy and 3 months of tapering doses) followed by a dose of RTX leads to a greater increase in the proportion of primary MN patients with…
The purpose of the study is to investigate the effect of CBD on specific ECG parameters. Importantly, it will be evaluated if there is a prolongation of the QT interval. When the QT interval is prolonged, repolarization of the heart is delayed. This…
The aim of the study is to assess if a dose reduction of craniospinal irradiation in children with a medulloblastoma does not reduce event free survival (EFS) or overall survival (OS). Furthermore it will be assessed if a field reduction (only tumor…
The primary objective is to compare the efficacy of moxifloxacin 400 mg PO OD for five days with the respective efficacy of amoxicillin clavulanic acid 875/125 mg PO BID for seven days in the treatment of subjects with AECB. The primary efficacy…
Primary objectives:- To improve the clinical effectiveness of the p53 synthetic long peptides vaccine by pre-administration of cyclophosphamide.- To evaluate the immunogenicity of a p53 synthetic long peptide vaccine when preceded by administration…
Primary Objective: The main objective of this prospective clinical trial is to compare pharmacokinetics and safety and tolerability of a standard dose (400 mg) with an escalated dose of 600 and 800 mg MFX. Secondary Objectives: * To evaluate limited…
The purpose of part A of the study is to investigate how safe the study drug is and how well the study drug is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed and eliminated from the body. The…
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…
The primary objective of the study is to reject the Null hypothesis: A 7 to 21 day therapy with moxifloxacin, 400 mg once daily is more than 10 % less effective than a 7 to 21 day therapy with piperacillin/tazobactam three times daily possibly…
As of protocol Amendment 06, evaluation of the safety profile of MLN9708 and/or other study medication is the only endpoint being assessed. All other study endpoints will no longer be assessed.
Primary:To assess the safety, tolerability and determine recommended phase 2 dose (RP2D) of NY-ESO-1 and LAGE-1a specific T cells, alone or in combination with other agents, in HLA-A*02-positive participants with NY-ESO-1 and/or LAGE-1a positive…
Primary:• To evaluate the safety and tolerability of autologous genetically modified T-cells (GSK3377794) in human leukocyte antigen (HLA) HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 positive participants with NY-ESO-1 and/or LAGE-1a positive…
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…
Objectives: - to increase the proportion of patients with non-severe GVHD within 180 days post-allo-SCT - to reduce the progression rate - to improve the progression free survival- to asses the impact on the quality of life using a time restricted…