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DNA Methyltransferase Inhibitor

Sabatolimab + HMAs for Myelodysplastic Syndrome

Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Morphologically confirmed diagnosis of a myelodysplastic syndrome (MDS) primary or secondary based on 2016 WHO classification (Arber et al 2016) by investigator assessment with one of the following Prognostic Risk Categories, based on the International Prognostic Scoring System (IPSS-R). Note: MDS diagnosis history will be recorded in the CRF:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, every 12 weeks up to approximately 36 months
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new cancer drug, MBG453, when used in combination with other approved cancer drugs.

Who is the study for?
Adults diagnosed with higher-risk Myelodysplastic Syndrome (MDS) who haven't had certain treatments like chemotherapy for MDS. They should be in a condition where stem cell transplant isn't an option, have decent organ function, and can follow study procedures. Those with other cancers or who've had organ transplants aren't eligible.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Sabatolimab combined with Hypomethylating Agents (HMAs), which are FDA-approved drugs for MDS treatment. These include intravenous Decitabine, Azacitidine, or oral Decitabine (INQOVI).See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, blood count abnormalities that could lead to infections or bleeding problems, fatigue, gastrointestinal issues like nausea or constipation, and liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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 condition is a type of blood disorder classified as MDS.
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My kidney function, measured by eGFR, is at least 30 mL/min/1.73m2.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, every 12 weeks up to approximately 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every 12 weeks up to approximately 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Complete remission (CR) rate according to International Working Group (IWG) for MDS (2006) * as per investigator assessment by 12 months.
Duration of complete remission
Leukemia-free survival
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: MBG453 (sabatolimab) + HMAExperimental Treatment4 Interventions
MBG453 + HMA (azacitidine, decitabine, or INQOVI (oral decitabine))
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MBG453
2017
Completed Phase 1
~250
Azacitidine
2012
Completed Phase 3
~1440
Decitabine
2004
Completed Phase 3
~1680

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,615 Total Patients Enrolled

Media Library

Azacitidine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04878432 — Phase 2
Myelodysplastic Syndrome Research Study Groups: MBG453 (sabatolimab) + HMA
Myelodysplastic Syndrome Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04878432 — Phase 2
Azacitidine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04878432 — Phase 2

Frequently Asked Questions

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

Will this research project be enrolling octogenarians?

"In order to participate in this particular clinical trial, applicants must fall between the ages of 18 to 99. There are 466 other trials for individuals under 18 and 1485 for those 65 and older."

Answered by AI

Could you provide some context for MBG453's role in past medical research?

"MBG453 was first studied 16 years ago at Central Illinois Hematology Oncology Center. Since then, there have been 271 completed clinical trials and 278 live trials. The majority of these ongoing trials are based in Peoria, Illinois."

Answered by AI

For what purpose is MBG453 most commonly indicated?

"Not only is MBG453 useful for induction chemotherapy, but this medication can also help patients that have been diagnosed with leukemia, myelocytic, acute as well as refractory anemias."

Answered by AI

Are we still enrolling people in this research project?

"Yes, according to the most recent update on clinicaltrials.gov, this trial is currently recruiting patients. The trial was first posted on March 17th, 2022 and was last updated on June 21st, 2022. The study is looking for 90 participants between 18 different locations."

Answered by AI

Could I participate in this research if I qualify?

"This study seeks to enroll 90 individuals that currently have muscular dystrophy. To be eligible, participants must meet the following age, performance, and health requirements: - Be between 18-99 years old - Have an ECOG performance status of 0, 1, or 2 - AST and ALT ≤ 3x ULN - Total bilirubin ≤ 2 x UNL (with exception for Gilbert syndrome) - eGFR ≥ 30 mL/min/1.73m2"

Answered by AI

What is the regulatory standing of MBG453?

"As this is a Phase 2 trial, there is some data suggesting MBG453 is safe for human use. However, as there are no trials supporting efficacy, it only received a score of 2."

Answered by AI

At how many different sites is this trial being conducted?

"Currently, Illinois Cancer Care P.C., IL Cancer Specialists in Peoria, Illinois; Mayo Clinic Arizona in Phoenix, Arizona; and Arizona Oncology Associates - Arizona Oncology Assoc PC in San Antonio, Texas are enrolling patients for this clinical trial. Along with these 18 other locations."

Answered by AI

What is the cap on how many people can join this particular research project?

"The sponsor, Novartis Pharmaceuticals, needs to recruit a total of 90 patients that meet the study's inclusion criteria from multiple sites including Illinois Cancer Care P.C. IL Cancer Specialists in Peoria, Illinois and Mayo Clinic Arizona in Phoenix, Arizona."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS
2022. "STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04878432.
~29 spots leftby Apr 2025
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