Trial Projects

The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.

The main objectives of this trial are: 1.) Demonstration of non-inferiority of VCD induction therapy compared to PAd induction therapy with respect to response rate (very good partial remission or better; response criteria of the International Myeloma Working Group, IMWG).

2.) Determination of the best of four treatment strategies with respect to progression-free survival (PFS). The four treatment strategies are defined by PAd vs. VCD induction treatment, standard intensification therapy, ...

Study Design The study included a lenalidomide cohort and a background cohort. Patients in both cohorts had received ≥ 1 prior antimyeloma therapy and were required to have never received lenalidomide. Enrolled patients who were treated on the study with lenalidomide for off-label indications were kept in the study. To achieve a patient population reflective of those treated in real-world clinical practice, there were few restrictions on eligibility. Exclusion criteria were refusal to participate ...

Brief Summary 5-azacytidine treatment prolongs survival in patients with myelodysplastic syndrome (MDS), but does not cure the disease. Allogeneic stem cell transplantation is a curative treatment option but is associated with a high risk treatment-related morbidity and mortality. In the current trial allogeneic stem cell transplantation will be compared to 5-azacytidine only treatment according to donor availability in elderly patients with MDS (55-70 years).

Detailed Description ...

This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.