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Monoclonal Antibodies
BMS-986497 for Leukemia and Myelodysplastic Syndrome
Montreal, Canada
Phase 1
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
Detectable levels of cluster of differentiation 33 (CD33) expression
Must not have
Acute Promyelocytic Leukemia
Clinically active central nervous system leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to test the safety and effectiveness of a drug called BMS-986497 in patients with relapsed or refractory acute myeloid leukemia (AML) or myelodyspl
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Who is the study for?
This trial is for individuals with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants should have these conditions confirmed and not be responding to standard treatments. Specific eligibility criteria are not provided, but typically include factors like age, health status, and prior treatment history.Check my eligibility
What is being tested?
The study is testing BMS-986497's safety, tolerability, how the body processes it, its effectiveness in treating AML/MDS, and to establish the appropriate dosage. It's likely that participants will receive varying doses of BMS-986497 to find out which one works best with manageable side effects.See study design
What are the potential side effects?
While specific side effects of BMS-986497 are not listed here, common ones for cancer drugs may include nausea, fatigue, risk of infection due to low blood cell counts, bleeding or bruising easily from low platelets count and potential liver function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have AML or MDS that has come back or didn't respond to treatment.
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Select...
My cancer cells show CD33.
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Select...
I have tried other treatments that didn't work for me.
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Select...
I can care for myself and my organs are functioning well.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with Acute Promyelocytic Leukemia.
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Select...
I have active leukemia in my brain or spinal cord.
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Select...
I have an active cancer that is not blood-related.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part 2: Dose Expansion BMS-986497Experimental Treatment1 Intervention
Group II: Part 1: Dose Escalation BMS-986497Experimental Treatment1 Intervention
Find a Location
Closest Location:Local Institution - 0003· Montreal, Canada
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,727 Previous Clinical Trials
4,128,734 Total Patients Enrolled