15 results
To assess the effect of SLT on the frequency of soft (stool of type 3, 4 or 5 on the Bristol Stool Form Scale (BSFS)) complete bowel movements (SCBMs) and SCBMs non-straining (NS) per week in subjects taking World Health Organisation (WHO) step II/…
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…
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 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…
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…
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: To evaluate the effects of multiple subcutaneous (SC) doses of elamipretide on left ventricular end systolic volume (LV ESV) assessed by cardiac Magnetic Resonance Imaging (MRI)Secondary:* To evaluate the safety and tolerability of multiple…
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…
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.
Therapy:The investigational product, ACP-196, will be supplied as hardgelatin capsules for oral administration.Commercially available ibrutinib (IMBRUVICA®) will be used asthe reference therapy.Objectives: Primary Objective:To assess whether ACP-196…
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).
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…
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 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 (…