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Anti-metabolites

MBG453 + Azacitidine + Venetoclax for Acute Myeloid Leukemia (STIMULUS-AML1 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
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 , 2 or 3
Not planned for hematopoietic stem-cell transplantation (HSCT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 weeks (starting at week 5) for up to 48 months from last patient first treatment
Awards & highlights

STIMULUS-AML1 Trial Summary

This trial will study whether a combination of MBG453 with azacitidine and venetoclax is more effective than azacitidine and venetoclax alone in treating patients with blood cancer.

Who is the study for?
This trial is for adults over 18 with newly diagnosed Acute Myeloid Leukemia (AML) who can't handle intensive chemotherapy due to age, weak heart or lungs, liver or kidney issues, or other health problems. They must understand the study and agree to participate without planning for a stem cell transplant.Check my eligibility
What is being tested?
The trial tests MBG453 combined with azacitidine and venetoclax in AML patients unfit for strong chemo. It aims to see if this mix works better than previous treatments by extending earlier promising results.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system since MBG453 targets it, as well as typical chemotherapy-related issues like nausea, fatigue, risk of infection from low blood counts, and potential liver function changes.

STIMULUS-AML1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may not be able to do heavy physical work.
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I am not scheduled for a bone marrow transplant.
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I am 18 years old or older.

STIMULUS-AML1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks (starting at week 5) for up to 48 months from last patient first treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks (starting at week 5) for up to 48 months from last patient first treatment 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 (Safety run-in patients only)
Percentage of subjects achieving complete remission (CR)
Secondary outcome measures
ADA prevalence on-treatment
Anti-drug Antibody (ADA) prevalence at baseline
Peak Serum Concentration (Cmax) MBG453
+11 more

STIMULUS-AML1 Trial Design

1Treatment groups
Experimental Treatment
Group I: MBG453+Venetoclax +AzacitidineExperimental Treatment3 Interventions
Patients will receive MBG453 in combination with Venetoclax and Azacitidine
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
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,260 Total Patients Enrolled

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04150029 — Phase 2
Acute Myeloid Leukemia Research Study Groups: MBG453+Venetoclax +Azacitidine
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04150029 — Phase 2
Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04150029 — Phase 2

Frequently Asked Questions

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

What is the present enrolment size of this clinical research?

"Sadly, recruitment for this clinical trial is no longer available. First posted on September 1st 2020 and last updated November 23rd 2022, it has since closed its doors to new participants. However, there are presently 1534 studies allowing enrolment of leukemia patients and 345 trials recruiting individuals with MG453."

Answered by AI

What are the intended benefits of this medical investigation?

"The primary target of this trial, monitored throughout a minimum six cycles ranging from patient's first treatment up to 100 weeks (each cycle 28 days), is the prevalence of dose-limiting toxicities. The secondary objectives are calculating peak and trough serum concentrations of MBG453 as well as measuring how many subjects achieve CR or CRi while having no minimal residual disease in the general population."

Answered by AI

What precedent has been established for the usage of MBG453 in clinical trials?

"MBG453 was first examined in 2006 at the Chinese University of Hong Kong-Prince of Wales Hospital. Thus far, there have been a total 208 trials completed and there are currently 345 active studies being run throughout New york City."

Answered by AI

What diseases can be alleviated with MBG453?

"MBG453 has been approved for induction chemotherapy, yet it may also be able to help patients with refractory anemias, leukemia, myelocytic disorders and acute multilineage dysplasia."

Answered by AI

Has MBG453 been given the seal of approval by the FDA?

"Based on the scope of research conducted so far, our team assigned MBG453 a score of 2 in terms of safety. Specifically, this Phase 2 trial provides some evidence for its safety but no data confirming efficacy."

Answered by AI

Is enrollment in this trial currently open?

"Unfortunately, this medical trial is not currently seeking new enrollees. It was originally posted on the 1st of September 2020 and its information was last updated on November 23rd 2022. If you are still hoping to participate in a clinical study, there are presently 1534 trials for leukemia sufferers that accept participants as well as 345 studies recruiting volunteers for MBG453 specifically."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy
2020. "A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04150029.
~30 spots leftby Mar 2026
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