15 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 ObjectiveTo investigate the possible efficacy of combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in increasing sexual satisfaction during sexual activity in the domestic setting in healthy female subjects with…
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 test the hypothesis that once daily tadalafil administered orally for 48 weeks lessens the decline in ambulatory ability as measured by the 6MWD compared to placebo in boys with Duchenne muscular dystrophy (DMD). Two…
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:- To evaluate the efficacy of the combination of temozolomide with vincristine and irinotecan in children and adult patients with relapsed rhabdomyosarcoma as assessed by confirmed objective tumor response.Secondary:- To evaluate the safety…
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…
Primary objectivesMeasuring the SARS-CoV-2-specific immune response against SARS-CoV-2 after inoculation with a single-dose Janssen compared to a homologous vaccination regimen with Janssen /Janssen and the comparison of a homologous vaccination…
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…
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 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.
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-…
Key objective The key objective of the study to determine whether it is necessary to boost the healthy population in autumn. Primary endpoint: The primary endpoint is to determine the fold change in antibody level at day of boost and 28 days after…
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 Primary Objectives of the Phase 1b are: • To assess the safety and tolerability of carfilzomib, alone and in combination with induction chemotherapy, for the treatment of children with relapsed or refractory ALL • To determine the maximum…