High-Risk Myelodysplastic Syndrome (STIMULUS-MDS1)

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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

Overview

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

Study Goal

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.

All drugs are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Eligibility

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

If you're interested in this clinical study, your doctor can help evaluate whether you are eligible to participate. Ask your doctor if your medical history or other treatments you're receiving may conflict with the study protocol. If you meet the eligibility criteria and agree to participate in the study: You will be required to sign an informed consent form (ICF). The ICF contains information about the study, which your doctor can help explain to you before you sign. Your doctor will need to complete the necessary tests to see if you are eligible. As with all clinical trials, you have the right to leave the study at any time, for any reason.

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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.

Definitions:
HSCT - hematopoietic stem cell transplantation, ICF - informed consent form, IPSS-R - Revised International Prognostic Scoring System, MDS - myelodysplastic syndrome

Last Updated: July 31, 2019

8/19 M-GON-1216065