22 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…
Primary objectives Part A:To test the non-inferiority, as evaluated by OS, of three courses of HDCT compared to focal RT plus conventional chemotherapy as consolidation therapy following conventional chemotherapy in children with ATRT aged 12 - 35…
The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab (E + R-CHOP) can prolong progression-free survival (PFS) compared with 6 cycles of standard R-…
In this open-label extension study, we look at how safe and effective the new medicinal product called bimekizumab (hereafter called the *study drug*) is for long-term treatment of hidradenitis suppurativa. Open label means that both you and your…
The hypothesis is that personalised and risk-adapted treatment will improve outcome and reduce toxicity in post-pubertal patients with medulloblastoma.A further hypothesis is that clinical, magnetic resonance imaging (MRI) and voxel-based…
The aim of this study is to reduce the indication for RT without compromising cure rates. To investigate if intensified consolidation therapy (DECOPDAC-21) compared to standard consolidation therapy (COPDAC-28) can compensate for reduction in RT.
Primary objective:- To confirm in a multicenter setting an improvement in EFS to 95% at 2 years of DA-EPOCH-R in patients with newly diagnosed high risk Burkitt lymphoma as compared to an expected EFS of 72% at 2 years for the control arm R-CODOX-M/…
The purpose of this study is to find out how safe and effective a new drug called bimekizumab is for long-term use in treating hidradenitis suppurativa. Bimekizumab (hereafter referred to as *the study drug*) has been approved by the health…
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…
The objectives of this clinical trial are as follows:1. To assess the safety and tolerability of OLT1177 Capsule after oral administration in subjects with an acute gout flare2. To assess the clinical activity of various doses of OLT1177 Capsule in…
The objectives of this clinical trial are as follows:1. To assess the safety, tolerability, and pharmacokinetics of dapansutrile capsules after oral administration in subjects with chronic, well-controlled Schnitzler*s syndrome 2. To assess the…
This study aims to investigate whether the administration of VCR in children with acute lymphoblastic leukemia, nephroblastoma, low-grade glioma, Hodgkin lymphoma and rhabdomyosarcoma by one-hour infusions, resulting in lower peak plasma…
Primary objectiveThe primary objective of this study is to evaluate the efficacy of bimekizumab in subjects with moderate to severe HS.Secondary objectiveThe secondary objective of this study is to assess the safety, tolerability, immunogenicity,…
PRIMARY OBJECTIVES*Phase 1 Dose Finding Studies:-To determine the recommended phase II dose (RP2D) of new systemic therapy regimens. *Frontline chemotherapy questions:-To compare systemic therapy regimens for patients with VHR disease at diagnosis (…
The main objectives of the trial are to:• evaluate the safety of venetoclax monotherapy.• determine dose limiting toxicities (DLT) and the recommended Phase 2 dose (RPTD) of venetoclax monotherapy.• assess the pharmacokinetics (PK) of venetoclax…
The primary objective is to assess the clinical efficacy of dapansutrile versus placebo in subjects presenting with moderate COVID-19 respiratory symptoms and evidence of early cytokine release syndrome.Secondary objectives are to assess:* Complete…
This study aims to demonstrate the effectiveness of dabrafenib with trametinib in pediatric patients with BRAF V600 mutant relapsed refractory HGG.This study aims to demonstrate the effectiveness of dabrafenib with trametinib compared to…
Objective(s): Primary objective:The primary objective is to demonstrate the efficacy of bimekizumab administered subcutaneously (sc) every 4 weeks (Q4W) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).…
Primary Objective:The primary objective of this study is to compare the efficacy of bimekizumab administered scfor 16 weeks versus secukinumab at achieving complete clearance (PASI100) in subjects withmoderate to severe chronic plaque PSO.The…
The primary objective of this open-label extension (OLE) study is to assess the long-term safety and tolerability of bimekizumab administered over a period of up to 112 weeks.