16 results
- To assess, in a randomized study the value of Azacitidine as post remission therapy (in comparison to observation) in elderly patients with AML, RAEB or RAEB-t with respect to the disease free survival.- In addition, post remission Azacitidine…
Although these products have been used extensively in patients, the effect of these medications on experimental pain sensation has never been investigated. There is little knowledge about any direct effect of these medications on pain perception. In…
Primary Objectives:Safety Run-in PartTo establish a safe and tolerable dose of azacitidine to be used in the randomized part of thestudy.Randomized PartTo evaluate the effect of azacitidine treatment in AML subjects at molecular relapse after…
Primary• To determine in patients with higher-risk myelodysplastic syndrome (HR MDS), chronic myelomonocytic leukemia (CMML), and low-blast acute myelogenous leukemia (AML) whether the combination of pevonedistat and azacitidine improves event-free…
Primary objectives:* Part 1: To evaluate the safety and tolerability and determine the recommended dose(s) of INCB059872 for further study in advancedmalignancies.* Part 2: To further evaluate the safety and tolerability of INCB059872 for further…
The primary objective is to assess the treatment effect on response rate (MDS: either completeremission [CR], partial remission [PR], or marrow CR; JMML: either clinical completeremission [cCR] or clinical partial remission [cPR]); at Cycle 3 Day 28…
Primary Objective:To evaluate RBC transfusion independence in the 2 treatment arms (oral azacitidine plus best supportive care versus placebo plus best supportive care) in subjects with RBC transfusion-dependent anemia and thrombocytopenia (platelet…
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.
Primary ObjectivesThe current study aims to establish the recommended dose, safety and preliminary efficacy of azacitidine administered IV or SC in children with relapsed/refractory MDS or JMML, in 2 different subgroups (strata) of patients.…
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 anti-TIM-3 monoclonal antibody MBG453 is a novel immunotherapeutic agent with promising activity seen in AML and MDS. The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with…
Phase 1b Dose-finding Stage Primary Objectives· To assess the safety and tolerability of the combination treatments of oral AG-120 when administered with subcutaneous (SC) azacitidine and oral AG-221 when administered with SC azacitidine in subjects…
Primary Objective:* To compare event-free survival (EFS) between AG-120 + azacitidine and placebo + azacitidine. Key Secondary Objectives:* To compare the complete remission (CR) rate between AG-120 + azacitidine and placebo + azacitidine. EFS is…
To assess the efficacy of venetoclax in combination with AZA compared to placebo with AZA in treatment-naive higher-risk MDS.
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…
Primary:• To compare the efficacy of magrolimab + venetoclax + azacitidine versus placebo + venetoclax + azacitidine in patients with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy as measured by…