← Back to Search

Anti-metabolites

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

Zurich, Switzerland

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

Must not have

Subjects with Myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber et al 2016) with revised International Prognostic Scoring System (IPSS-R) ≤ 3

Diagnosis of therapy related myeloid neoplasms based on WHO 2016 classification (Arber et al 2016)

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

Pivotal 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.

See full description

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.

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.

show original

Select...

I am 18 years old or older.

show original

Select...

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

show original

Select...

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

show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My condition is classified as MDS with a low to intermediate risk score.

show original

Select...

My condition is classified as a therapy-related myeloid neoplasm.

show original

Select...

I have been diagnosed with a type of acute myeloid leukemia.

show original

Select...

I have had an organ or bone marrow transplant.

show original

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.