20 results
The primary objective is to examine whether a memory impairment as a result of biperiden treatment (cholinergic M1 antagonist) will be increased by acute tryptophan depletion (ATD, a drink that decreases serotonin synthesis). In other words, we will…
The primary objective is to examine whether a memory impairment as a result of biperiden treatment (cholinergic M1 antagonist) can be reversed by rivastigmine (a cholinesterase inhibitor). Secondary, we will assess the effects of biperiden and…
The primary objective is to demonstrate the efficacy in subjects with R/R T-PLL treated with venetoclax plus ibrutinib.
• To determine the profile of CNS effects at several time points after 2 mg and 4 mg biperiden in comparison to placebo in healthy elderly subjects.• To investigate the safety and tolerability of biperiden in healthy elderly subjects.• To determine…
The objective of this study is to collect long-term safety and efficacy data for subjects treated with PCI-32765 and to provide ongoing access to PCI-32765 for subjects who are currently enrolled in PCI-32765 studies that have been completed…
We will examine the cognitive performance of healthy young participants at different time points after a single administration of biperiden. The behavioural outcomes and electrophysiological correlates will be linked with the serum levels of…
Primary objective- To evaluate the efficacy of 6 cycles ibrutinib/obinutuzumab in converting patients who are not in CR or who have detectable MRD on combination ibrutinib and venetoclax in uMRD (BM) CR Secondary objectives- To explore the kinetics…
Primary ObjectiveThe primary objective of the study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review…
Run-in Part (Part 1)Objectives Primary* Confirm that the pharmacokinetics in pediatric subjects is consistent with that in adults Secondary* Evaluate the safety and tolerability of ibrutinib in combination with RICE or RVICI background therapy in…
Primary Objective: Safety Run-in Period:To evaluate the occurrence of tumor lysis syndrome (TLS) and doselimiting toxicities (DLTs) with the concurrent administration of ibrutinib and venetoclax.Randomization Phase:To evaluate whether the…
Primary objectives1. To assess in a randomized comparison the effect of Ibrutinib added to 10-day decitabine treatment on the cumulative CR/CRi rate after 3 cycles.Secondary objectives1. To assess the safety and tolerability of Ibrutinib added to 10…
Primary ObjectiveThe primary objective of this study is to evaluate whether the addition of ibrutinib to bendamustine and rituximab will result in prolongation of PFS in subjects with newly diagnosed MCL who are 65 years of age or older.Secondary…
The primary objective: - Evaluate efficacy of ibrutinib + venetoclax (VI) in terms of proportion of patients fulfilling the criteria for progression free survival (PFS) at 12 months after stopping therapy (27 months after starting treatment) for…
Analysis Study:To evaluate whether the addition of ibrutinib to rituximab will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma.
The primary objective of the study is to evaluate the efficacy of obinutuzumab(GA101) plus venetoclax (GVe) versus standard chemoimmunotherapy (BR/FCR)[concerning MRD negativity measured by flow cytometry in peripheral blood (PB)at month 15] and…
To compare progression-free survival (PFS) of LOXO-305 as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL).
The primary objective of the study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients…
Part A - Dose Finding/SafetyPrimary Objective:* To determine the recommended pediatric equivalent dose (RPED; based on pharmacokinetic [PK] and, if applicable,pharmacodynamic data) for use in pediatric subjects (age >=1 to <12 years)…
The primary objectives of the study are to characterize the safety and toxicity profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of…
To establish one of three study arms, R-CHOP/R-DHAP followed by ASCT (control arm A), R-CHOP + ibrutinib / R-DHAP followed by ASCT and ibrutinib maintenance (experimental arm A+I), and R-CHOP + ibrutinib / R-DHAP followed by ibrutinib maintenance (…