EUCTR2019-002089-11-FI进行中（未招募）1 期
A randomized, double-blind, placebo-controlled phase III multi-center study of azacitidine with or without MBG453 for the treatment of patients with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Key inclusion criteria:
- •Signed informed consent must be obtained prior to participation in the study
- •Age = 18 years at the date of signing the informed consent form (ICF)
- •Morphologically confirmed diagnosis of myelodysplastic syndrome (MDS) based on WHO 2016 classification (Arber et al 2016) by local investigator assessment with one of the following Prognostic Risk Categories, based on the revised International Prognostic Scoring System (IPSS-R):
- •Very high (> 6 points)
- •High (> 4.5 - = 6 points)
- •Intermediate (> 3 - = 4.5 points)
- •Morphologically confirmed diagnosis of Chronic Myelomonocytic
- •Leukemia -2 based on WHO 2016 classification (Arber et al 2016-persistant PB monocytosis = 1 x109/L and monocytes accounting for = 10% of the WBC differential count)) by local investigator assessment with WBC < 13 x 10^9/L at time of diagnosis
- •Indication for azacitidine treatment according to the investigator,
- •based on local standard medical practice and institutional guidelines for
- •treatment decisions
- •Not eligible at time of screening for intensive chemotherapy according
- •to the investigator, based on local standard medical practice and
- •institutional guidelines for treatment decisions, including assessment of
- •individual clinical factors such as age, comorbidities and performance
- •Not eligible at time of screening for hematopoietic stem cell
- •transplantation according to the investigator, based on local standard
- •medical practice and institutional guidelines for treatment decisions,
- •including assessment of individual clinical factors such as age,
- •comorbidities, performance status and donor availability
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0,
- •Please refer to protocol for further details and any additional inclusion
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 350
排除标准
- •Key exclusion criteria:
- •Prior exposure to TIM-3 directed therapy at any time. Prior therapy
- •with immune checkpoint inhibitors (e.g, anti-CTLA4, anti-PD-1, anti-PDL1,
- •or anti-PD-L2), cancer vaccines is allowed except if the drug was
- •administered within 4 months prior to randomization
- •Previous first-line treatment for intermediate, high, very high risk
- •myelodysplastic syndromes (based on IPSS-R) or CMML-2 with any
- •antineoplastic agents including for example chemotherapy, lenalidomide
- •and hypomethylating agents (HMAs) such as decitabine or azacitidine.
- •However, previous treatment with hydroxyurea or leukopheresis to
- •reduce WBC count is allowed prior to randomization.
- •Investigational treatment received within 4 weeks or 5 half-lives of
- •this investigational treatment, whatever is longer, prior to
- •randomization. In case of a checkpoint inhibitor: a minimal interval of 4
- •months prior to randomization is necessary to allow randomization.
- •Subjects with Myelodysplastic syndrome (MDS) based on 2016 WHO
- •classification (Arber et al 2016) with revised International Prognostic
- •Scoring System (IPSS-R) = 3
- •Diagnosis of acute myeloid leukemia (AML) including acute
- •promyelocytic leukemia and extra-medullary acute myeloid leukemia,
- •primary or secondary myelofibrosis based on WHO 2016 classification
- •(Arber et al 2016)
- •Diagnosis of therapy related myeloid neoplasms based on WHO 2016
- •classification
- •(Arber et al 2016)
- •History of organ or allogeneic hematopoietic stem cell transplant
- •Please refer to protocol for further details and any additional exclusion
研究者
相似试验
进行中（未招募）
1 期
A study to test whether pazopanib can prevent or delay kidney tumor coming back after the tumor has been removedRenal Cell CarcinomaEUCTR2010-020965-26-SKovartis Pharma Services AG1,500
进行中（未招募）
1 期
A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib - BAY73-4506 Phase III GIST 3rd/4th lineEUCTR2009-017957-37-FRBayer HealthCare AG170
进行中（未招募）
1 期
Study of Reparixin combined with paclitacel compared to paclitaxel alone in patients with metastatic Triple-negative breast cancerEUCTR2014-004796-23-PLDompé Farmaceutici s.p.a.123
进行中（未招募）
1 期
16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsEUCTR2013-001090-24-BEovartis Pharma Services AG222
进行中（未招募）
1 期
A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEEUCTR2006-000470-78-FRGlaxoSmithKline Research and Development Limited