Hradec Kralove

Researchers are evaluating the safety and effectiveness of ravulizumab compared to placebo in adult patients at high risk of delayed graft function DGF following deceased donor kidney transplantation. The study aims to show whether ravulizumab can reduce the severity of DGF, specifically by shortening the time patients need dialysis after transplant. This phase 3, randomized, double-blind trial focuses on patients with dialysis-dependent end-stage kidney disease receiving kidneys from specific donor types. Participants will be randomly assigned to one of two groups one receiving intravenous infusions of ravulizumab, and the other receiving placebo infusions. The treatment is given intravenously, and participants receive either the study drug or placebo throughout the study. The trial compares these groups to assess the impact on DGF. The study is conducted across multiple centers and follows participants through 90 days after transplantation to measure outcomes. Throughout the study, participants will undergo regular assessments to monitor their kidney function and dialysis needs. Researchers will measure the time until participants no longer require dialysis, the number of dialysis sessions needed, the incidence of DGF within 7 days post-transplant, and kidney function as measured by eGFR. Safety and efficacy data are collected during the post-transplant period, with primary outcome measurements taken through 90 days after transplant. The total participation period extends until the studys completion in 2028.

Researchers are evaluating the effectiveness and safety of a limited-duration combination therapy using acalabrutinib and venetoclax in patients with relapsed chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study focuses on patients who previously responded to a first-line combination treatment of covalent BTKi plus BCL2i, with or without obinutuzumab, and maintained a response for at least two years after that treatment. This phase 2 study aims to assess overall response rates and outcomes for this second-line treatment approach. Participants are grouped into low or high disease risk cohorts based on genetic markers such as IGHV mutation and TP53 aberrancy. The treatment begins with 2 cycles of acalabrutinib alone, followed by combination therapy with acalabrutinib and venetoclax for either 12 or 22 cycles depending on the risk group. After treatment, participants enter a follow-up period lasting up to 3 or 4 years, making the total study duration around 5 years for each participant. During the study, participants will undergo regular evaluations including response assessments at various treatment cycles, monitoring of progression-free and overall survival, and measurement of minimal residual disease after treatment. Safety and tolerability of the combination therapy will be closely tracked throughout the 5-year period. Participants will have scheduled visits for treatment administration, laboratory tests, and clinical assessments to monitor their health and study outcomes.