High-Risk Myelodysplastic Syndrome (STIMULUS-MDS1)
A Randomized, Double-blind, Placebo-controlled Phase II Multi-center Study of Intravenous MBG453 Added to Hypomethylating Agents in Adult Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R Criteria
|This Study Is Recruiting: Phase II||Actual Start Date: [June 4, 2019]||Estimated Completion Date: [August 3, 2023]||Novartis Reference Number: CMBG453B12201|
|Condition: High-Risk MDS||Interventions: MBG453, decitabine, azacitidine, placebo||Estimated Enrollment: [120 participants]||ClinicalTrials.gov Identifier: NCT03946670|
|This Study Is Recruiting: Phase II||Actual Start Date: [June 4, 2019]|
|Estimated Completion Date: [August 3, 2023]||Novartis Reference Number: CMBG453B12201|
|Condition: High-Risk MDS||Interventions: MBG453, decitabine, azacitidine, placebo|
|Estimated Enrollment: [120 participants]||ClinicalTrials.gov Identifier: NCT03946670|
This Phase II is a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R intermediate, high or very high risk myelodysplastic syndrome (MDS) not eligible for Hematopoietic Stem Cell Transplantation (HSCT) or intensive chemotherapy.
Participants may be eligible to participate if they:
- Are 18 years or older
- Have a confirmed diagnosis of MDS with one of the following prognostic risk categories (per IPSS-R grading system): very high-, high-, or intermediate-risk with ≥5% blasts
- Are not suitable for intensive chemotherapy
- Have no planned hematopoietic stem cell transplantation
- Meet other eligibility criteria
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To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.
HSCT - hematopoietic stem cell transplantation, ICF - informed consent form, IPSS-R - Revised International Prognostic Scoring System, MDS - myelodysplastic syndrome
Last Updated: July 31, 2019