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Anti-metabolites
Iadademstat + Azacitidine for Myelodysplastic Syndrome
Phase 1
Waitlist Available
Led By Guru Subramanian Guru Murthy, MD, MS
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male subjects must meet contraceptive requirements
Patient is able to swallow oral medications
Must not have
Had major surgery within 4 weeks prior to the first study dose
Patients with known active congestive heart failure, long QT Syndrome, or recent stem cell transplantation or CAR-T therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to find the right dose of iadademstat combined with azacitidine for adults with myelodysplastic syndrome.
Who is the study for?
This trial is for adults with Myelodysplastic Syndrome (MDS), a condition that can lead to leukemia. Participants should not have received certain treatments before and must meet specific health requirements, which will be determined by the study team.
What is being tested?
The trial is testing different doses of a drug called Iadademstat in combination with Azacitidine to find the safest and most effective dose for treating MDS. It's an early-stage study (phase I) focused on dosage recommendations.
What are the potential side effects?
Potential side effects may include typical reactions associated with cancer drugs such as nausea, fatigue, blood count changes, and increased risk of infection. Specific side effects related to Iadademstat or Azacitidine will be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am following the required contraceptive measures.
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I can swallow pills.
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My weight is at least 50 kg.
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I have been diagnosed with MDS, MDS/MPN, or CMML according to WHO criteria.
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My condition is classified as intermediate, high, or very-high risk according to IPSS-R.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had major surgery less than 4 weeks ago.
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I do not have active heart failure, long QT Syndrome, or recent cell therapy.
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I have been treated with drugs that affect cell DNA or LSD1 before.
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My blood pressure or diabetes is not well-managed.
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I am allergic or react badly to ingredients in the treatment drugs.
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I currently have an infection that isn't under control.
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I have issues absorbing nutrients due to past GI surgery or disease.
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I have a liver condition or hepatitis B or C.
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I am HIV positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recommended phase II dose of Iadademstat.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Maximum Tolerated Dose (MTD)Experimental Treatment3 Interventions
The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a dose-limiting toxicity.
Group II: Dose level 1Experimental Treatment2 Interventions
This is a regimen of azacitidine and iadademstat.
Group III: Dose level 0Experimental Treatment2 Interventions
This is a regimen of azacitidine and iadademstat.
Group IV: Dose level -1Experimental Treatment2 Interventions
Dose level -1 will be considered only if there are dose-limiting toxicities at dose level 0. This is a regimen of azacitidine and iadademstat.
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
635 Previous Clinical Trials
1,181,693 Total Patients Enrolled
Guru Subramanian Guru Murthy, MD, MSPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials