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DNA Methyltransferase Inhibitor

sabatolimab for Myelodysplastic Syndrome (STIMULUS-MDS3 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study completion, up to 3 years
Awards & highlights

STIMULUS-MDS3 Trial Summary

This trial is testing a new drug to see if it's safe and if it has benefits for people with MDS who can't have other types of treatment.

Eligible Conditions
  • Myelodysplastic Syndrome

STIMULUS-MDS3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study completion, up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study completion, up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities (DLTs) (Safety run-in patients only)
Percentage of participants (receiving 800mg sabatolimab) achieving complete remission (CR) per investigator assessment
Secondary outcome measures
Anti-drug Antibody (ADA) prevalence at baseline and ADA incidence on-treatment by dose level
Changes in fatigue (Part 2 - Expansion)
Duration of CR/mCR
+13 more

STIMULUS-MDS3 Trial Design

1Treatment groups
Experimental Treatment
Group I: sabatolimab + azacitidine + venetoclaxExperimental Treatment3 Interventions
Part 1: Safety run-in consists of 2 subsequent cohorts of a lower dose (cohort 1) and s higher dose (cohort 2) of sabatolimab in combination with fixed dose of venetoclax and azacitidine. Cohort 2 will be open only after the review of safety data from cohort 1 indicates the regimen is safe. If the regimen using sabatolimab at the lower dose is not safe, the study will be stopped. Subsequently, if the review of safety data from participants enrolled in cohort 2 indicates that the regimen is safe, then Part 2 will be opened. Otherwise, if the regimen at the higher dose is not safe, the study will be also stopped. Part 2: Expansion will enroll additional participants to further investigate the regimen including sabatolimab at the higher dose, azacitidine and venetoclax. Participants data from Part 1 and Part 2 treated with the higher dose will be combined to determine the complete remission rate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
azacitidine
2005
Completed Phase 3
~1740
sabatolimab
2021
Completed Phase 2
~20
venetoclax
2021
Completed Phase 2
~750

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,857 Previous Clinical Trials
4,197,781 Total Patients Enrolled

Frequently Asked Questions

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

Are any more recruits being taken for this research project?

"Unfortunately, this research study is not presently taking on any new candidates. The trial was first posted in May of 2021 and last updated in November 2022. Those searching for other clinical trials may find 1595 preleukemia studies and 345 sabatolimab trials recruiting participants."

Answered by AI

Are there any adverse effects associated with sabatolimab treatment?

"Although there is limited evidence for the efficacy of sabatolimab, it does have some clinical support regarding safety and was thus given a score of 2."

Answered by AI

What prior research has been conducted concerning sabatolimab?

"Presently, there are 345 clinical investigations being conducted for sabatolimab. Of these trials 54 have reached the third phase of development while most occur in Edmonton, Alberta; however, 11 321 sites across the world offer this experimental therapy."

Answered by AI

What are the key aims of this investigation?

"According to the clinical trial sponsor, Novartis Pharmaceuticals, this medical experiment will be measuring a number of primary and secondary objectives over its duration of up to three years. The main objective includes tracking dose-limiting toxicities (DLT). Additionally, researchers are assessing event-free survival (EFS), overall response rate (ORR) after participants have achieved hematologic improvement or better, and trough serum concentration levels for MBG453."

Answered by AI

What is the total sample size of participants in this research project?

"This investigation is no longer looking for participants. It was first posted on May 31st of 2021, and the last update to its listing occurred November 9th 2022. For individuals in search of other clinical trials, there are presently 1595 experiments recruiting patients diagnosed with preleukemia and 345 studies searching for sabatolimab candidates."

Answered by AI

What is sabatolimab typically prescribed to treat?

"Sabatolimab is widely used for induction chemotherapy and can treat a variety of illnesses such as refractory anemias, leukemia, myelocytic anaemia, acute dysplasia and multilineage dysplasia."

Answered by AI
~5 spots leftby Apr 2025