EUCTR2019-002089-11-FI
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)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Pharma AG
- Enrollment
- 500
- Status
- Active, not recruiting
- Last Updated
- 2 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\-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,
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\-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
Outcomes
Primary Outcomes
Not specified
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