← Back to Search

Anti-metabolites

MBG453 + Azacitidine for Myelodysplastic Syndrome (STIMULUS-MDS2 Trial)

Phase 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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):

Age ≥ 18 years at the date of signing the informed consent form

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 8 of each cycle (1 cycle = 28 days) until cycle 9, at day 8 of cycle 12 and every 6 cycles thereafter up to 150 day after end of study drug

Awards & highlights

STIMULUS-MDS2 Trial Summary

This trial is a Phase III, randomized, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high risk myelodysplastic syndrome or Chronic Myelomonocytic Leukemia-2.

Who is the study for?

Adults diagnosed with intermediate to very high risk myelodysplastic syndrome (MDS) or Chronic Myelomonocytic Leukemia-2 (CMML-2), who need azacitidine treatment but can't have intensive chemotherapy or stem cell transplants. Participants must be over 18, able to consent, and have an ECOG performance status of 0-2.Check my eligibility

What is being tested?

The trial is testing the effectiveness and safety of a drug called MBG453 when combined with Azacitidine in treating MDS and CMML-2. It's a Phase III study where patients are randomly assigned to receive either MBG453 or a placebo alongside Azacitidine.See study design

What are the potential side effects?

Potential side effects for participants could include reactions at the injection site, blood count abnormalities, gastrointestinal symptoms like nausea or vomiting, fatigue, and possible immune-related effects due to MBG453.

STIMULUS-MDS2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My condition is officially diagnosed as MDS based on the latest criteria.

Select...

I am 18 years old or older.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

My leukemia is confirmed and falls within a specific severity range with certain white blood cell counts.

STIMULUS-MDS2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 8 of each cycle (1 cycle = 28 days) until cycle 9, at day 8 of cycle 12 and every 6 cycles thereafter up to 150 day after end of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 8 of each cycle (1 cycle = 28 days) until cycle 9, at day 8 of cycle 12 and every 6 cycles thereafter up to 150 day after end of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 8 of each cycle (1 cycle = 28 days) until cycle 9, at day 8 of cycle 12 and every 6 cycles thereafter up to 150 day after end of study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival

Secondary outcome measures

Anti-drug Antibody (ADA) prevalence at baseline and ADA incidence on-treatment

Change from baseline in the European Quality of Life (EuroQoL) - 5 Dimensions, 5 Level Questionnaire (EQ-5D-5L) Visual Analogue Scale over time

Change from baseline in the European Quality of Life (EuroQol) - 5 Dimensions, 5 Level Questionnaire (EQ-5D-5L) score over time

+14 more

STIMULUS-MDS2 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MBG453 (Sabatolimab) + AzacitidineExperimental Treatment2 Interventions

Participants will receive MBG453 plus Azacitidine

Group II: Placebo + AzacitidinePlacebo Group3 Interventions

Participants will receive Placebo plus Azacitidine

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,196,823 Total Patients Enrolled

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04266301 — Phase 3

Chronic Myelomonocytic Leukemia Research Study Groups: MBG453 (Sabatolimab) + Azacitidine, Placebo + Azacitidine

Chronic Myelomonocytic Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04266301 — Phase 3

Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04266301 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any contraindications for MBG453?

"The safety of MBG453 is estimated to be a 3 on a scale from 1 to 3. This is because it is a Phase 3 trial, which means that there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

For what purpose is MBG453 most commonly indicated?

"MBG453 is a medication used to kill cancer cells. It can also help patients with 20-30% blasts, neutropenia and/or thrombocytopenia, and anemia."

Answered by AI

Can people with the specified condition join this trial at this time?

"This study is not recruiting at the moment. The listing was originally posted on June 8th, 2020 and was last updated on July 28th, 2020. There are currently 2801 trials actively recruiting patients with leukemia, myelomonocytic, chronic and 184 studies for MBG453 actively recruiting participants."

Answered by AI

In how many different medical institutions is this research being conducted currently?

"There are a total of 18 hospitals and cancer centres participating in this trial, these are: Yuma Regional Cancer Center in Yuma, UCLA Medical Center in Iowa City, University of Iowa Hospitals and Clinics Univ of Iowa Hosp & Clinic in Albuquerque. The other 18 locations can be found ____."

Answered by AI

How many guinea pigs are they letting in on this experiment?

"2801 other studies are currently recruiting patients with leukemia, myelomonocytic, chronic and 184 trials are enrolling participants for MBG453."

Answered by AI

What previous research exists on the use of MBG453?

"The original clinical trial for MBG453 occurred in 2006 at Chinese University of Hong Kong-Prince of Wales Hospital. Since then, a total of 18397 clinical trials have been completed. At present, there are 184 active clinical trials, with a large number of these occurring in Yuma, Arizona."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

2020. "Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04266301.

All > Mds > Myelodysplastic Syndrome