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Epigenetic Modifying Agents

MBG453 + Hypomethylating Agents for Myelodysplastic Syndrome (STIMULUS-MDS1 Trial)

Phase 2

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

Very high

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 months after last patient first visit (lpfv)

Awards & highlights

STIMULUS-MDS1 Trial Summary

This trial is testing a new drug, MBG453, to see if it can help people with myelodysplastic syndrome who can't have a stem cell transplant or intensive chemotherapy.

Who is the study for?

Adults with intermediate to very high risk Myelodysplastic Syndrome (MDS) who can't have a stem cell transplant or intensive chemo. They must be over 18, understand the study's consent form, and not have had certain treatments for MDS before, like chemotherapy or immune checkpoint inhibitors within specific time frames.Check my eligibility

What is being tested?

The trial is testing MBG453 combined with hypomethylating drugs (azacitidine or decitabine) against a placebo plus those same drugs in adults with risky MDS. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real treatment versus placebo.See study design

What are the potential side effects?

Possible side effects of MBG453 may include reactions at the injection site, fatigue, fever, bone marrow suppression leading to low blood cell counts which increases infection risk. Hypomethylating agents can also cause nausea, bruising due to low platelets and anemia.

STIMULUS-MDS1 Trial Eligibility Criteria

Inclusion Criteria

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

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You have a very high risk or condition that makes participation in the study unsafe.

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

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My bone marrow has at least 5% blast cells.

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I am 18 years old or older.

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My condition is officially diagnosed as MDS, fitting specific risk categories.

STIMULUS-MDS1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 months after last patient first visit (lpfv)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 months after last patient first visit (lpfv)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months after last patient first visit (lpfv) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Complete Remission (CR) Rate

Progression Free Survival (PFS)

Secondary outcome measures

Duration of Complete Remission

Event Free Survival

Immunogenicity of MBG453 When Given in Combination of Hypomethylating Agents

+7 more

STIMULUS-MDS1 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MBG453 + hypomethylating agentsExperimental Treatment2 Interventions

Patients are taking MBG453 plus hypomethylating agents

Group II: Placebo + hypomethylating agentsPlacebo Group2 Interventions

Patients are taking placebo plus hypomethylating agents

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MBG453

2017

Completed Phase 1

~250

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,226 Total Patients Enrolled

Media Library

Hypomethylating agents (Epigenetic Modifying Agents) Clinical Trial Eligibility Overview. Trial Name: NCT03946670 — Phase 2

Myelodysplastic Syndrome Research Study Groups: MBG453 + hypomethylating agents, Placebo + hypomethylating agents

Myelodysplastic Syndrome Clinical Trial 2023: Hypomethylating agents Highlights & Side Effects. Trial Name: NCT03946670 — Phase 2

Hypomethylating agents (Epigenetic Modifying Agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03946670 — Phase 2

Frequently Asked Questions

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

Is this experiment a pioneering attempt in its field?

"Presently, 12 clinical trials for MBG453 are being conducted in 133 cities and 42 countries. This drug was first tested back in 2017 by Novartis Pharmaceuticals on 243 patients as part of a Phase 1 approval process; since then, 18,321 studies have been undertaken."

Answered by AI

What adverse effects has MBG453 been demonstrated to have on individuals?

"As MBG453 is currently in its second stage of trials, there's some indication that the medication is safe. Thus, our team at Power has allocated a score of 2 to this drug."

Answered by AI

What are the desired outcomes of this clinical investigation?

"Novartis Pharmaceuticals, the sponsoring company of this trial, reports that Progression-Free Survival (PFS) is its primary measure over a period of 7 months post Last Patient First Visit. Secondary objectives include Duration of Complete Remission, Response Rate, and Time to Complete Remission."

Answered by AI

Are there any prior investigations that have utilized MBG453?

"Currently, 12 investigations into MBG453 are ongoing with 1 trial in its final phase. Despite being heavily concentrated in Toon-city, Ehime, there are 379 clinical sites across the globe running trials for this drug."

Answered by AI

Is this research endeavor still accepting new volunteers?

"This trial has ceased to accept patients; the original post date was June 4th 2019, and it was last modified on November 21st 2022. For those seeking similar medical trials, there are 1592 myelodysplastic syndromes studies that remain open for enrollment and 12 MBG453 investigations actively recruiting participants."

Answered by AI

How many participants are currently enrolled in the trial?

"This study is no longer accepting new patients. It was first created on June 4th 2019 and the most recent edit occurred on November 21st 2022. Currently, there are 1,592 clinical trials recruiting participants with myelodysplastic syndromes and 12 studies that include MBG453 as part of their admission criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).

2019. "A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03946670.

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