11 results
To define and implement an uniform initial evaluation and stratification on adult patients with LCH, to uniform the treatment of adult patients with LCH and to improve treatment results with respect to survival, therapy response, prevention of…
The main objective of this trial is to assess whether treatment adaptation based on a very early FDG-PET results in improved efficacy while minimizing treatment toxicity in advanced stage HL patients treated with BV-containing regimens, BrAVD and…
Primary:• To evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in subjects with phenylketonuria (PKU) as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (ie, the average of each respective…
PRIMARY OBJECTIVE:- To show that it is possible to cure at least 75% of patients belonging to the SR group with Vinblastine-monotherapy for 24 months.SECONDARY OBJECTIVE: - To describe overall survival and treatment related mortality of 24 months…
The purpose of the study is to investigate to what extent DA-3880 is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to the above mentioned Aranesp® formulation. In addition, the effect DA-3880 on the number of…
The main objective of the trial is to show that ABVD-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (BEACOPP) in case of a positive FDG-PET after one cycle of ABVD, has non-inferior efficacy…
The aim of the trial is to individualize treatment for each patient by adapting it to early response and to treat only those patients with addiotional radiotherapy who show an inadequate treatment response. The degree of treatment response is…
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:• To evaluate the long-term safety of PTC923 in subjects with phenylketonuria (PKU)• To evaluate changes from baseline in dietary phenylalanine (Phe)/protein consumptionSecondary:• To evaluate PTC923 effect on quality of life (QOL) using the…
The primary objective is to compare the objective response rate (ORR) per Response Assessment in Neuro Oncology (RANO) criteria assessed by independent review committee (IRC) of DAY101 monotherapy versus standard of care (SoC) chemotherapy in…
Primary objective:To improve the PET negativity after two cycles of immuno-chemotherapyPrimary efficacy endpoint:PET 2 assessment according to the five-point scale Deauville criteria (Negative = 1, 2, 3 and Positive = 4, 5), based on central review.…