23 results
This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in patients with PPMS, including patients later in their disease course.
This study will evaluate the efficacy and safety of ocrelizumab in patients with early stage relapsing remitting multiple sclerosis (RRMS).The objective of the Immune Substudy is to explore immunological changes associated with ocrelizumab treatment…
Primary:To investigate the efficacy of ocrelizumab compared with placebo in patients with primary progressive multiple sclerosis, as measured by thetime to onset of confirmed disability progression over the treatment period, defined as an increase…
To assess and compare efficacy (complete response [CR] rate and overall survival [OS]) between SGI-110 and TC in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.
The primary objective of the study is to assess in patients with primary colon cancer whether short-course pre-operative treatment with decitabine can increase Wnt target gene expression as measured in resected tumors compared to pretreatment…
The primary objective of this study is to compare, in a randomized phase III trial, the effect of 10-day decitabine at a dose of 20 mg/m2 versus conventional induction chemotherapy (*3+7*) on OS in older AML patients.
This study will evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis (RRMS) who have a suboptimal response to an adequate course of a disease modifying treatment (DMT).
Primary* To compare the composite complete remission (CRc) rate (morphologic complete remission [CR] and morphologic CR with incomplete hematologic recovery [CRi]) between treatment arms * To compare overall survival (OS) between treatment…
The primary objective of this study is to assess the feasibility (safety and efficacy) of addition of 10-day decitabine to the standard Seattle non-myeloablative conditioning regimen (3 days fludarabine 30 mg/m2 + 2 Gray TBI) prior to allogeneic HCT…
Primary ObjectivesPhase 1 portion:• to determine the maximum tolerable dose (MTD) of cytarabine (up to 2 g/m2/day x 5) that can be administered on Days 8-12 following treatment with DACOGEN 20 mg/m2/day on Days 1-5 of a 28 day cycle. • to determine…
The primary objective of this study is to assess whether the efficacy of ocrelizumab given as two dose regimens of 600 mg (given as 300 mg infusions on days 1 and 15 and 600 mg infusion in the following cycles) or 400 mg (given as 200 mg infusions…
Primary objectives:• To assess early mortality risk (first 30 days after start of induction therapy) of treatment with decitabine-cytarabine in elderly patients with AML or high risk myelodysplastic syndrome (IPSS >=1.5) with a high risk of…
The goal of the present study is to investigate the effect of head cooling after kickboxing matches on cognitive functioning amongst both amateur and professional kickboxers. Based on the above mentioned studies, it is hypothesized that head cooling…
The objective of this prospective, randomized study is to investigate the efficacy and safety of HSCT compared to the comparator group (alemtuzumab, cladribine or ocrelizumab) in patients with aggressive relapsing remitting MS. In Norway, the…
With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of MS disease activity (clinically and radiologically) compared to the standard (fixed 24 week interval) treatment.
Primary objective:Part I- To asses the feasibility of addition of post-transplant panobinostat combined with decitabine to a regimen of T-cell replete RIC alloHSCT in patients with very poor risk AML/RAEB, and select the dose level for the phase II…
This Extension study will evaluate the effectiveness and safety of ocrelizumab in MS patients who were previously enrolled in a Roche sponsored ocrelizumab phase IIIb/IV parent trial.
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…
This study will evaluate the efficacy, safety, and pharmacokinetics of a higher dose of ocrelizumab compared with the approved dose of ocrelizumab in patients with relapsing forms of multiple sclerosis.
Primary: To characterize the safety and tolerability of PDR001 and/or MBG453 in combination with decitabine or azacitidine in relapsed/refractory AML patients, de novo AML patients not candidates for standard induction therapy, or high risk or…