16 results
Use of iron chelation therapy has demonstrated benefits in terms of morbidity and mortality for chronically-transfused thalassemia patients with iron overload. Recent retrospective data (Leitch 2007, Rose 2010, Sanz 2008) suggest that overall…
The primary objective of the study is to determine concentration of circulation cytokines na administration of LPS in the presence of iron sucrose (Venofer®), Deferasirox (Exjade®) of placebo.
To study the safety and efficacy of deferasirox as treatment of oxidative stress in adult subjects with sickle cell disease.
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…
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…
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…
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.
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…
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 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…
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).
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 (…