EUCTR2019-002089-11-IT
Active, not recruiting
Phase 1
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)
Conditionsadult subjects with intermediate, high or very high risk (per IPSS-R prognostic risk categories) myelodysplastic syndrome or with Chronic Myelomonocytic Leukemia - 2 (CMML-2)MedDRA version: 20.0Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851MedDRA version: 21.0Level: PTClassification code 10009018Term: Chronic myelomonocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- adult subjects with intermediate, high or very high risk (per IPSS-R prognostic risk categories) myelodysplastic syndrome or with Chronic Myelomonocytic Leukemia - 2 (CMML-2)
- Sponsor
- ovartis Pharma AG
- Enrollment
- 500
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\) by local investigator assessment with WBC \< 13 x 10^9/L
- •Indication for azacitidine treatment according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions
- •Not eligible for intensive chemotherapy according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions
Exclusion Criteria
- •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\-PD\-L1, 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 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 criteria.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A study to test whether pazopanib can prevent or delay kidney tumor coming back after the tumor has been removedEUCTR2010-020965-26-SKovartis Pharma Services AG1,500
Active, not recruiting
Phase 1
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
Active, not recruiting
Phase 1
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
Active, not recruiting
Phase 1
16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsEUCTR2013-001090-24-BEovartis Pharma Services AG222
Active, not recruiting
Phase 1
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