21 results
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…
To assess the efficacy of nab-paclitaxel administered intravenously (IV) on Days 8and 15 with epigenetic modifying therapy of CC-486 once daily (QD) on Days 1 to14 every 21 days, and nab-paclitaxel monotherapy administered IV on Days 1 and 8every 21…
- 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…
The purpose of this trial is: • to study the effect of a single dose of GAL-054 (the test medication) in healthy volunteers on the functioning of the body, especially on respiration, and compare this with the effect of a single dose of doxapram.• to…
The purpose of this study is testing a respiratory stimulant, doxapram. Painkillers such as morphine and alfentanil mute breathing. This is often undesirable, especially in patients. To counteract this attenuation is often used drugs also take away…
The aim of this pilot study is;* To determine whether differences between individuals in the set-point of the HPT-axis can be determined by using this study-design,* To examine whether this study design is practicable and tolerated by the healthy…
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 objective:- To assess safety, efficacy, and potentially select the most active treatment regimen among 3 treatment arms to advance to the Phase 3 component of the study.Secondary objectives:- Ph1b: evaluate PK & assess immunogenicity…
Primary Objective:Efficacy:· Evaluate the efficacy of subcutaneous (sc) azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in the defined study population.Secondary Objectives:Safety:· Assess the safety and…
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 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…
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* 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…
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…
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…
This study has been transitioned to CTIS with ID 2024-511722-31-00 check the CTIS register for the current data. Phase 1b Dose-finding Stage Primary Objectives· To assess the safety and tolerability of the combination treatments of oral AG-120 when…
This study has been transitioned to CTIS with ID 2023-510144-20-00 check the CTIS register for the current data. The current study is designed to evaluate the preliminary safety and efficacy of BLU-263 in patients with AdvSM, including in those with…
This study has been transitioned to CTIS with ID 2023-507153-16-00 check the CTIS register for the current data. To assess the efficacy of venetoclax in combination with AZA compared to placebo with AZA in treatment-naive higher-risk MDS.
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…
The main objective of our trial is to investigate if doxapram is safe and effective in reducing the composite outcome of death and neurodevelopmental impairment/severe disability at 2 years corrected age as compared to placebo.